REQUIREMENTS FOR NOTIFICATION OF CONFORMITY ASSESSMENT

BODIES AND CONFORMITY ASSESSMENT PROCEDURES

Guidance for regulators and conformity assessment bodies on the

conformity assessment aspects of EU Decision No. 768/2008/EC

February 2009

Foreword

Decision No. 768/2008/EC lays down common principles and reference provisionsintended to apply across sectoral legislation in order to provide a coherent basis forrevision of current or future legislation harmonising the conditions for the marketing of products. It provides, in the form of reference provisions (i.e. standard text), definitions and general obligations for economic operators and a range of conformity assessment procedures from which the Commission, Council, and the European Parliament can select as appropriate when drafting or revising Single MarketDirectives. Of importance for this guidance document are the reference provisionson the requirements for conformity assessment bodies to be notified to the Commission as competent to carry out the relevant conformity assessmentprocedures and as regards the notification procedures.

The Department for Innovation, Universities & Skills (DIUS) is responsible for the conformity assessment aspects of the Decision; for all other aspects, the Department for Business Enterprise & Regulatory Reform (BERR) takes the lead.

The European Commission will be updating its definitive guidance (“blue book”) in due course. This DIUS guidance is therefore only interim till the Commission update.

This guidance has no legal force. While every effort has been made to ensure that it is consistent with the Decision, DIUS cannot accept liability for any errors, omissionsor misleading statements in it. In case of difficulty, enquires can be addressed to:

Rose Newton quoting “Conformity Assessment Policy” Bay 208 Innovation Delivery Department for Innovation, Universities & Skills Kingsgate House 66-74 Victoria Street London SWIE 6SW

Phone: 020 3300 8627 Email: rose.newton@dius.gsi.gov.uk

1

CONTENTS

Page

Introduction 3

A Guide to conformity assessment policy on the requirements for notification 5of conformity assessment bodies and conformity assessment procedures

- Conformity assessment procedures 5

- Reference provisions for Community legislation laying down the 5conditions for the marketing of products

Annex A Structure of the European Commission Decision 18

Annex B Definitions in the Decision 20

Annex C Conformity assessment procedures in community legislation: 22Modules

Annex D European Commission document on the differences between 27conformity assessment modules as laid down in New Approach (Decision 93/465/EEC - old modules) and as laid down in the New Legal Framework (Decision 768/2008/EC - new modules)

Annex E Model structure of the EC Declaration of Conformity 61

Annex F Sources of information 62

2

Introduction

Purpose The Decision aims to improve the quality of future Community harmonisation legislation by providing the authors of future legislation with a common set of ‘tools’. These tools comprise reference provisions (i.e. standard text), definitions, general obligations to economic operators, conformity assessment procedures, rules on CE marking and safeguard provisions that the author can select as appropriate for the specific legislation they are writing. Using these tools will provide coherence as well as inter-sectoral uniformity of all such legislation concerning the product and thus avoids ad-hoc variants. The Decision therefore constitutes a general horizontal framework for future legislation harmonising the conditions for the marketing of products and a reference text for existing legislation.

Guidance on applying and using these tools relating to the requirements for notification of conformity assessment bodies, conformity assessment procedures and conformity of the product is at sections 1 - 4 below.

Scope This Decision lays down common principles and reference provisions intended to apply across sectoral harmonising legislation, for example, product directives that are based on the New Approach principles.

Timing The Decision was published in the Official Journal on 13 August 2008 with immediate effect, and so can be used now by EU regulators, for example, when a product directive is considered for amendment.

Application Although there is no legal obligation on regulators to apply the requirements of the Decision in future legislative Acts, by adopting this Decision, Member States have signed up to a clear political commitment which should be respected in any future EU legislative act falling within the scope of this Decision. The legislators must use the provisions of the Decision, except where justified due to the specific sectoral requirements, for example in the fields of medical devices, construction products and marine equipment. The Decision will only affect national regulations when Community harmonising regulations, for example product directives, are revised taking account of the provisions of the Decision resulting in the revision of the national regulations.

The general structure of the Decision is given in Annex A.

3

Origin In order to further the single market and establish a level playing field for accreditation bodies and conformity assessment bodies throughout Europe, the European Commission proposed a “goods package1” of new legislation as part of the review of the New Approach comprising an Regulation (EC) No 765/2008, hereinafter referred to as “the Regulation”, that will be directly applicable law on 1 January 2010 - setting out the requirements for accreditation and market surveillance relating to the marketing of products (and repealing Regulation EEC No 339/93), and an associated EU Decision (No 768/2008/EC), hereinafter referred to as “the Decision”, on a common framework for the marketing of goods (and repealing Decision 93/465/EEC). The third measure in the package is the Regulation (EC) No 764/2008 on Mutual Recognition which lays down procedures relating to the application of technical rules to products that have been lawfully marketed in another Member State. The package was approved by the Council of Ministers on 23 June 2008.

Background This Decision does not have immediate legal consequences in Member States. It is directed towards the institutions of the European Union. It is designed to constrain departure from its provisions when new legislation in this area is proposed, so that when new proposals for product legislation come forward (whether they are new, or are being revised or for amendment) the European Commission, Council and the Parliament will be obliged to cast the law using the provisions set down in the Decision as the common framework.

The Commission therefore expects any sectoral proposals adopted from now onwards to be drafted on this basis so that such negotiations would only concentrate on matters that are unique to a piece of legislation e.g. defining its scope, drafting appropriate essential requirements and choosing appropriate conformity assessment procedures on the basis of expert risk assessment. The Decision is therefore intended to be a robust future model for harmonisation of all European product legislation in respect of the relevant features that it covers.

Conformity assessment is important for business and consumers in demonstrating that what is being supplied actually meets the requirements specified or claimed. Its application in the UK generally follows a statement of principles that were set down in a document prepared by the then Department of Trade & Industry: http://dius.ecgroup.net/Search.aspx?URN=07/594. This principles document will be amended in due course to take account of the provisions of the Regulation.

1 See http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:218:SOM:EN:HTML

4

A guide to the conformity assessment policy aspects of the Decision on the requirements for notification of conformity assessment bodies and conformity assessment procedures

The conformity assessment procedures

The Decision, among other things, lays down provisions on conformity assessment procedures, and requires that where they are to be used in legislation they must be chosen from the those procedures listed in Annex I to the Decision. These procedures are explained further in section 3 in this guidance.

Reference provisions for Community harmonisation legislation

Harmonising legislation, like the current product directives, contain reference provisions relating to conformity assessment bodies (CABs) - for example their technical competence, independence and insurance requirements - which Member States have to observe when they designate them as notified bodies to carry out conformity assessment procedures. Sections 1 - 3 in this guidance describe the definitions, and main conformity assessment provisions in the Decision that apply to CABs at EU level in terms of criteria for notification, for such bodies wishing to be appointed as notified bodies: the notification procedure to follow; the obligations on notified bodies and notifying authorities; and the use of conformity assessment procedures (modules). Section 4 describes the provisions in the Decision relating to the conformity of the product, for example allowing harmonised standards to give a presumption of conformity to essential requirements, possibility to object to a harmonised standard and the drawing of a declaration of conformity attesting to the fulfilment of requirements specified in the harmonising legislation.

1. Definitions 1.1. One of the problems identified with current directives based on the principles of the New Approach was a lack of consistency in the use of definitions leading to diverging interpretations. To overcome this, the Decision lays down (in Article 1) specific definitions to be used in harmonising legislation, including those for “conformity assessment” and “conformity assessment bodies”. A full list of definitions is in Annex B to this guidance. A CAB is defined as a body that performs conformity assessment activities including calibration, testing, certification and inspection.

2. Notification of conformity assessment bodies 2.1. In certain circumstances the conformity assessment procedures prescribed by the applicable legislation, for example New Approach directives, require the intervention of third party CABs, which are notified by the Member States to the Commission. This requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services in the EU.

5

2.2. In addition, it is also necessary to set requirements that Member States’ notifying Government Departments and other bodies involved in the assessment, notification and monitoring of notified bodies have to fulfil. Since accreditation is an essential means of verifying the technical competence of CABs, the Decision not only encourages its use for the purposes of notification but requires Member States to consider it as the preferred means of demonstrating the competence. The system set out in the Decision is complemented by the accreditation system provided for in the Regulation on accreditation and market surveillance.

The Regulation requires that Member States appoint a single EU recognised national accreditation body (NAB) - with authority derived from the Member State. At present UKAS - the United Kingdom Accreditation Service, is the UK designated NAB.

Requirements relating to notifying authorities

2.3. The Decision not only sets obligatory requirements for CABs wishing to be notified in order to provide conformity assessment services but, in parallel, sets certain requirements relating to notifying authorities. The Decision requires that the notifying authority shall:

• be established in such a way that no conflict of interest with conformity assessment bodies occurs;

• be organised and operated so as to safeguard the objectivity and impartiality of its activities;

• be organised in such a way that each decision relating to notification of a CAB is taken by competent persons different from those who carried out the assessment;

• not offer or provide any activities that CABs perform or consultancy services on a commercial or competitive basis;

• safeguard the confidentiality of the information it obtains; • have a sufficient number of competent personnel at its disposal for the proper

performance of its tasks.

Requirements relating to notified bodies i.e. criteria for notification

2.4. The Decision lays down in Article R17 specific requirements that, once adopted in specific harmonising legislation, a CAB will have to meet to be eligible for appointment as a notified body in the EU under that legislation. Member States will need to ensure that notified bodies meet the requirements set out in the legislation in question (i.e. the specific transposition of the Article R17 requirements). The Decision further states that the preferred method of demonstrating the technical competence of those bodies is accreditation as provided for in the Regulation.

2.5. Where the CAB concerned cannot provide an accreditation certificate, it must provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements set out in the specific harmonising legislation.

2.6. The requirements set out in Article R17 of the Decision are as follows:

• A CAB shall be established under national law and have legal personality.

6

• A CAB shall be a third-party body independent of the organisation or the product it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

• A CAB, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the CAB or the use of such products for personal purposes. A CAB, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services. CABs shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

• CABs and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

• A CAB shall be capable of carrying out all the conformity assessment tasks assigned to it by the appropriate reference to the relevant part of the new harmonising legislation, and in relation to which it has been notified, whether those tasks are carried out by the CAB itself or on its behalf and under its responsibility. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary: o personnel with technical knowledge and sufficient and appropriate

experience to perform the conformity assessment tasks; o descriptions of procedures in accordance with which conformity

assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

o procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the

7

degree of complexity of the product technology in question and the mass or serial nature of the production process.

It shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

• The personnel responsible for carrying out conformity assessment activities shall have the following: o sound technical and vocational training covering all the conformity

assessment activities in relation to which the conformity assessment body has been notified;

o satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

o appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of Community harmonisation legislation and of its implementing regulations;

o the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

• The impartiality of the CABs, their top level management and of the assessment personnel shall be guaranteed. The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

• CABs shall take out liability insurance unless liability is assumed by the Member State in accordance with its national law, or the Member State itself is directly responsible for the conformity assessment.

• The personnel of a CAB shall observe professional secrecy with regard to all information obtained in carrying out their tasks under - the appropriate … reference to the relevant part of the harmonising legislation, or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

• CABs shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant Community harmonisation legislation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Application for notification and notification procedure

2.7. The following are procedural steps in the notification process as well as provisions in the Decision relating to when and how to notify, the basis of notification of CABs by Member States that meet the requirements and the assigning of an identification number to the notified body by the European Commission.

2.8. A CAB shall submit an application for notification to the notifying authority of the Member State in which it is established. The application shall be accompanied by a description of the conformity assessment activities, the conformity assessment

8

module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a NAB. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down.

2.9. Notifying authorities may notify only CABs which have satisfied the requirements. They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission: NANDO database - the New Approach Notified & Designated Organisations information system. The notification should include full details of the conformity assessment activities, the conformity assessment module or modules and product or products concerned and the relevant attestation of competence.

2.10. If the appointed body has not previously been assigned a NANDO identification number according to another EC directive, the Commission will assign such a number as part of the first notification process and this ID number will apply for any subsequent notifications in respect of other directives. The Commission will assign a single number to the appointed body even where the body is notified on NANDO under several Community acts. The notified body may begin working when the appointment has taken place, but it will not be able to issue any certificates until the notification appears on the NANDO website (see Annex F for address of the website).

2.11. Where a notification is not based on an accreditation certificate, the appropriate notifying Department will provide the Commission and the other Member States with documentary evidence which attests to the CABs competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down.

2.12. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used. The Commission and the other Member States should be notified of any subsequent relevant changes to the notification.

Presumption of conformity

2.13. Harmonised European and international standards exist, for example EN ISO 17000 series of standards, which are used as a basis for the assessment of a CAB (certification bodies, testing laboratories, inspection bodies) to help in establishing conformity with the requirements of the applicable harmonising legislation. Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out insofar as the applicable harmonised standards cover those requirements. However, it should be noted that each conformity assessment body standard is intended to be applicable to a wider range of activities

9

than the scope of appointment of a notified body. Therefore, for the presumption to be valid - the requirements in the standard must be related to the specific tasks to be performed according to the harmonising legislation.

Changes to notification

2.14. This section deals with provisions of the Decision on changes relating to a notified body that may have a bearing on its continued appointment as a notified body and the need to inform the appropriate notifying Department and the European Commission of these changes.

2.15. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down or that it is failing to fulfil its obligations, that Department shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It will immediately inform the Commission and the other Member States accordingly. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Subcontracting by notified bodies

2.16. CABs frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the products to be placed on the Community market, it is essential that where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out, and will inform the notifying authority accordingly. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established and keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them.

Obligations on notified bodies

2.17. The scope of a Directive defines the range of products, or hazards related to a product, or to a phenomenon, to which the related requirements in the Directive apply (the product scope). The scope of appointment of a notified body for a Directive sets out its entitlement to carry out certain tasks in relation to the product scope and includes the conformity assessment procedures for which it has been appointed and requirement to provide information to the notifying authority following any circumstances affecting the scope of appointment. This section sets out those obligations in the Decision.

2.18. The notified body shall carry out conformity assessment on products, or quality management systems as specified in its scope of appointment, in accordance with the conformity assessment procedures provided for in the Directive. The body must

10

ensure that it does not unreasonably restrict access to its services or place undue financial or other conditions upon manufacturers (or any others) seeking their services under relevant conformity assessment procedures e.g. conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.

2.19. Where a notified body finds that requirements laid down in the Directive or corresponding harmonised standards or technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate. In the course of the monitoring of conformity following the issue of a certificate, if a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.

2.20. The notified body shall inform the notifying authority of the occurrence of the following events:

• any refusal, restriction, suspension or withdrawal of a certificate;

• any circumstances affecting the scope of and conditions for notification;

• any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

• on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

Coordination of notified bodies

2.21. To minimise unnecessary burdens for economic operators, it is important that notified bodies apply conformity assessment procedures consistently and this is best achieved through appropriate coordination and cooperation between notified bodies. The Decision requires the Commission to ensure that appropriate coordination and cooperation between bodies notified under a directive are put in place and properly operated in the form of a sectoral or cross sectoral group of notified bodies. The Decision also requires Member States to ensure that the bodies notified by them participate in the notified body co-ordination group. This could be at national and European level.

Accredited in-house bodies

2.22. Whilst the above procedures and requirements are imposed on CABs that wish to be appointed as notified bodies, the Decision also lays down certain requirements for a company that has an in-house body which is accredited to carry out conformity assessment activities for the company. An accredited in-house body may be used to carry out conformity assessment activities for the company of which it forms a part for the purpose of implementing the conformity assessment procedures set out in modules A1, A2, C1 or C2 which are specified in Annex II of the Decision. A requirement is that the body shall constitute a separate and distinct part of the

11

company and shall not participate in the design, production, supply, installation, use or maintenance of the products it assesses. Such a body shall not be notified to the Member States or the Commission, but information concerning its accreditation shall be given by the company of which it forms a part or by the national accreditation body to the notifying Department at the request of that Department.

2.23. An accredited in-house body shall meet the following requirements:

• it shall be accredited in accordance with the Regulation (No 765/2008/EC); • the body and its personnel shall be organisationally identifiable and have

reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body;

• neither the body nor its personnel shall be responsible for the design, manufacture, supply, installation, operation or maintenance of the products they assess nor shall they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities;

• the body shall supply its services exclusively to the company of which it forms a part.

National requirements for notification

2.24. Whilst the above paragraphs apply to all Community CABs, this section gives a brief overview of the general requirements for notification at national level i.e. for a UK conformity assessment body wishing to be appointed as a notified body. As not all harmonising legislation is the same, (for example, certain requirements of the Construction Products Directive are different to other New Approach directives), for detailed notification requirements it is important that guidance specific to the individual directives or harmonising legislation should be consulted for further information. The assessment and appointment of notified bodies by government departments generally follows a statement of principles that were set down in a document prepared by the then Department of Trade & Industry: http://dius.ecgroup.net/Search.aspx?URN=98/1238.

2.25. Apart from certain directives (for example medical devices directive) where an application for appointment as a notified body is made to the relevant Government department, for most directives the application should be made in the first instance to the UK NAB - currently UKAS and information on the assessment process is available on their website (see Annex F for the address of the website). The UK NAB will carry out an assessment, based on harmonised standards, of the applicant body on behalf of the Secretary of State of the notifying Department against the requirements in the individual directive in question (i.e. the specific transposition of Article R17 of the Decision - see section 2.6), and provide a report and recommendation to the Secretary of State. The standards will give a presumption of conformity with the requirements as laid down. The applicant body shall provide evidence of its insurance (public liability insurance and professional indemnity) cover to the UK NAB before any appointment is made.

12

2.26. The Secretary of State for the appropriate notifying government Department will make a decision based on the recommendation and accompanying assessment from the UK NAB and any other relevant information. If the Secretary of State is satisfied that the applicant body is suitable, and therefore approves its appointment, a formal letter of appointment setting out the precise terms and conditions of appointment will be issued to the applicant body. That Department will then notify the Commission of the appointment via the NANDO database.

2.27. For continued appointment, the UK NAB will at regular intervals, carry out reassessment, seek evidence of continued appropriate insurance cover and surveillance of the notified body according to the conditions in the body’s letter of appointment and send a report to the Secretary of State of the notifying Department. The UK NAB will advise the Department if it believes that a notified body no longer complies with the terms of that body’s letter of appointment, including compliance with the requirements in this guidance, or when an accreditation that supports notification is re-instated following suspension, withdrawal, or a reduction in scope. In turn, that Department will advise the NAB if a notified body has decided to suspend its activities, or when an appointment and notification has been withdrawn or terminated.

3. Conformity assessment procedures

3.1. The old 1993 Decision (93/465/EEC) on Global Approach laid down general guidelines and detailed procedures for conformity assessment that are used in current New Approach directives. The aim of that Decision was to ensure that there was a consistent approach taken in the development of Community harmonising legislation by using a set of specific conformity assessment modules set down in its Annex for the various phases of conformity assessment procedures, and by laying down criteria for the use of these procedures for the designation of CABs. This aim equally extends to the new 2008 Decision.

3.2. Whilst in general, the principal guidelines in the Decision on the use of conformity assessment procedures in harmonising legislation are similar to those set down in the 1993 Decision, some of the inconsistencies attributed to the 1993 Decision were related to its generic nature which allowed conformity assessment procedures to depart from the modules when warranted by the specific circumstances of a particular sector or directive. However, the new Decision is much more specific, and states that where Community harmonisation legislation requires conformity assessment to be performed in respect of a particular product, the procedures which are to be used shall be chosen from among the modules set out and specified in Annex II (the modules) of the Decision, and in accordance with specific criteria as set down in Article 4 of the Decision.

3.3. Whereas the 1993 Decision clearly stated the use of EN 45000 series of harmonised standards in establishing competence of notified bodies through accreditation, the new Decision gives a presumption of conformity to the requirements relating to notified bodies set out in the Decision (as specified in Article R17), if a body demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official

13

Journal of the European Union. A programme of work is underway to ensure that the relevant standards are published in the Official Journal.

The modules

3.4. The modules are a set of harmonized methods for the assessment of conformity, and the adoption of a common EU approach for their implementation. The methods give the legislator a means to ensure that products are in full conformity with the essential requirements laid down in the technical harmonization legislation, in order to provide, in particular, for the health and safety of users and consumers. The legislators have to take into account, in setting the range of possible modules to use according to the principle of proportionality in particular, such issues as the type of products, the nature of the risks involved, the economic infrastructures of the given sector (such as the existence or non-existence of third parties), the types and importance of production to ensure a high degree of protection as defined in Article 95(3) of the EC Treaty. The higher the risk, the more stringent the requirement as to the involvement of third party conformity assessment (eg product testing), before a CE marking can be affixed to a product. Where a product is subject to the provisions of more than one directive, the objective is to provide the manufacturer with a common conformity assessment procedure contained in all the relevant directives or at least with compatible procedures.

3.5. The modules also allow the possibility of using procedures based on quality assurance techniques (modules D, E and H). Compliance with ISO 9001:2008 will give a presumption of conformity with the corresponding quality assurance modules as regards the provisions covered by the standard in question, provided that the quality system takes into consideration, as necessary, the specific requirements of the products for which they are implemented as well as fulfilling the essential requirements of the harmonising legislation.

3.6. Although the modules in the new Decision are essentially the same as those in the 1993 Decision, the text is significantly longer than the relevant parts of the old Decision. This is due to the text being expressed in full and in sufficient detail to avoid uncertainty or confusion. This will enable the sectoral legislation in the future to include the appropriate modules for each product category by direct reference to the relevant text in the Decision thus avoiding the need for the legislation itself to rewrite all the applicable modules and procedures and in a specific manner. Moreover, this also avoids the possibility of deviation from the standard text which is in line with the overall objective of the new Decision to serve as a general framework for technical harmonisation to which various sectoral legislation would make direct reference. Annex D lists the main differences between modules as laid down in Decision 93/465/EEC and new Decision 768/2008/EC.

3.7. The modules comprise a number of different conformity assessment procedures applicable to the widest range of products and relate to their design phase, production phase or both. Each module differs from the others with regard to the duties of the body responsible for testing and the stage in the manufacturing process at which such testing occurs. The modules range in complexity from manufacturer’s declaration of conformity without third party involvement to establishing approved

14

quality control systems at each stage of design, production and testing phases of manufacture.

3.8. There are eight basic modules, some of which have variants that can be combined with each other in a variety of ways in order to establish complete conformity assessment procedures. The purpose of the variants is to ensure the necessary level of protection for products presenting a higher level of risk without imposing a more complicated module, and without which the legislator would have to opt for a procedure that is more burdensome for manufacturers. Depending upon the applicable requirements in the harmonising legislation, a manufacturer could affix the CE marking without third party involvement, or involve a third party i.e. use of notified bodies. Only module A dealing with internal production control does not require the services of a notified body in order to place those products on the European market.

3.9. Annex C gives further information on the modules and their application, while the table below shows a simplified flow chart of how the different conformity assessment procedures are inter-related. All procedures lead to CE marking.

MODULE A

MODULE G

MODULE H

MODULE C

MODULE D

MODULE E

MODULE F

MODULE B

MA

NU

FAC

TUR

ER

CE

G

PRODUCTION PHASE DESIGN PHASE

MA

RK

IN

3.10. As mentioned above, the choice of modules set by directives or harmonising legislation, allows legislators to give the public authorities the high level of safety they seek for a given product or sector. The directives leave manufacturers as wide a choice as necessary to ensure compliance with the essential requirements of the directives. In addition, the directives will set out the criteria for a manufacturer to select the most appropriate module for his production from the modules specified in each directive.

15

3.11. For example, conformity assessment procedures in the Low Voltage Directive (2006/95/EC) on electrical equipment do not require a notified body to take action and it uses module A, where the level of risk is considered low. The manufacturer establishes a file of technical documentation enabling conformity of the product with the essential requirements of the directive to be assessed and draws up a written declaration of conformity declaring that the product meets applicable requirements.

3.12. Where the level of risk is considered high, as in equipment and protective systems intended for use in potentially explosive atmospheres (ATEX Directive 94/9/EC), manufactures could use module G to meet the essential requirements of the directive. In this case, a notified body examines individual product and ensures its conformity with essential requirements, and issues a certificate of conformity for the tests carried out. The manufacturer produces technical documentation regarding the design, manufacture and operation of the product and declares that the product concerned, which has been issued in accordance with the certificate of conformity issued by the notified body, conforms to the applicable requirements of the directive.

3.13. In other cases, different combinations of modules as specified in each directive allow a manufacturer to choose the most appropriate combination for his production. For example, in the Recreational Craft Directive (94/25/EC), in relation to the design and construction for boats from 12 m to 24 m hull length, manufacturers have the choice to meet the essential requirements using module B supplemented by module C, or D, or E or F. In this case, the directive also allows modules G or H to be used to meet the essential requirements of the Directive.

4. Conformity of the product

Presumption of conformity

4.1. One of the key principles of the New Approach is that the legislation lays down only performance-based and result-oriented essential requirements, without specifying technical solutions, in relation to safety. The detailed technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonised standards adopted in accordance with Directive 98/34/EC, and products that are manufactured in compliance with the harmonised standards benefit from a presumption of conformity with the corresponding essential requirements.

4.2. The Decision continues this important aspect of the New Approach and states that products which are in conformity with harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements covered by those standards. The publication of the reference of the standard in the Official Journal sets the date for the presumption of conformity to take effect.

16

Objection to a harmonised standard

4.3. The definition of a European standard has its origin in the technical standards and regulations Directive 98/34/EC. A harmonised standard is a European standard which is adopted by the European Standards Organisations and prepared in accordance with guidelines agreed between the Commission and the European Standards Organisations (CEN, CENELEC and ETSI), and is based on a mandate issued by the Commission after consulting the standing Committee established under Directive 98/34/EC. This consultation process provides a strong indication of the expectations of public authorities at national level.

4.4. The elaboration and adoption of harmonised standards is a consensus driven activity with input from all interested parties (for example, technical experts, public authorities, industry, consumer associations and trade unions), incorporating latest technical developments. To maintain the technical lead, standards are regularly reviewed. However, situations do arise where Member States or the Commission consider that a harmonised standard does not fully meet the essential requirements of a directive.

4.5. In such a situation, the Decision requires that the Commission or the Member State concerned bring the matter before the Standing Committee of Directive 98/34/EC, presenting its arguments. The Committee will consult the relevant European Standards Organisation and, in light of the Committee’s opinion, the Commission will decide to: publish; not to publish; to publish with restriction; to maintain; to maintain with restriction; or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union.

EC declaration of conformity

4.6. Most New Approach directives place an obligation on the manufacturer or its authorised representative within the Community, when they place a product on the market, to draw up a declaration of conformity which declares that the product satisfies the essential requirements. The Decision also allows Community harmonisation legislation that requires a declaration by a manufacturer that fulfilment of the requirements relating to a product has been demonstrated, to provide a single declaration in respect of all Community acts applicable to the product. The model structure of the declaration that should be used is set out in Annex E.

17

Annex A: Structure of the Decision

The general structure of the Decision is given below.

• Main articles - General principles for the drawing up of Community legislation for the marketing of products.

o In these provisions the Decision sets out the scope of the harmonising legislation in terms of a common framework of general principles and reference provisions for the marketing of products. It requires the harmonisation legislation to restrict itself to setting out the essential requirements determining the level of public protection except where this not possible or appropriate.

o It allows the use of harmonised standards providing for the presumption of conformity with the essential requirements. It lays down provisions for the selection, when required, of appropriate conformity assessment procedure chosen from among the modules set out and specified in its Annex II.

o It requires that the EC declaration of conformity provide all the relevant information in respect of all the Community acts applicable to the product. It all allows for the provision of conformity assessment, where required, to be carried out by public authorities, by manufacturers or notified bodies. Repeals Decision 93/465/EEC.

• Annex I - Reference provisions for Community harmonisation legislation for products.

o Chapter 1 lists key definitions including one for “conformity assessment”.

o Chapter 2 states the obligations of economic operators including authorised representatives, importers and distributors.

o Chapter 3 allows for products that are in conformity with harmonised standards to be presumed to be in conformity with the essential requirements of the harmonising legislation. There are provisions for formal objections to a harmonised standard which does not entirely satisfy the requirements which it covers. There are provisions on the structure of the EC declaration of conformity and provisions on affixing of the CE marking.

o Chapter 4 lays down provisions on the requirements relating to notifying authorities to notify conformity assessment. There are requirements for notified bodies including provisions on subcontracting and obligations to provide authorities with information on changes to the scope of their notification as well as coordination with other notified bodies. There are provisions allowing conformity assessment bodies who demonstrate compliance with harmonised standards shall presumed to comply with the requirements set out for notified bodies in the Decision. There are provisions on subcontracting by notified bodies and accredited in-house bodies used to carry out conformity

18

assessment activities. There are requirements on the application, the procedure to follow and changes to notification of conformity assessment bodies. There are obligations on notified bodies to carry conformity assessment as provided for in the harmonising legislation, and to provide information to the notifying authority of changes to the scope of their designation.

o Chapter 5 deals with safeguard procedures for products presenting a risk at national and Community levels.

• Annex II, which forms a substantial part of the text of the Decision, sets out the modules for the various phases of the conformity assessment procedures.

• Annex III, specifies the format for the EC declaration of conformity.

19

Annex B: Definitions as laid down in the Decision

• "making available on the market" shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

• "placing on the market" shall mean the first making available of a product on the Community market;

• "manufacturer" shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;

• "authorised representative" shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

• "importer" shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;

• "distributor" shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

• "economic operators" shall mean the manufacturer, the authorised representative, the importer and the distributor;

• "technical specification" shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;

• "harmonised standard" shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services on the basis of a request made by the Commission in accordance with Article 6 of that Directive;

• "accreditation" shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

• "national accreditation body" shall mean the sole body in a Member State that performs accreditation with authority derived from the State;

• "conformity assessment" shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

• "conformity assessment body" shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection;

20

• "recall" shall mean any measure aimed at achieving the return of a product that has already been made available to the end user;

• "withdrawal" shall mean any measure aimed at preventing a product in the supply chain from being made available on the market;

• "CE marking" shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing;

• "Community harmonisation legislation" shall mean any Community legislation harmonising the conditions for the marketing of products.

21

Ann

ex C

: C

onfo

rmity

ass

essm

ent p

roce

dure

s in

Com

mun

ity le

gisl

atio

n

DES

IGN

PH

ASE

Mod

ule

A:

al p

rodu

ctio

n co

ntro

l M

odul

e B

: pe

exa

min

atio

n M

odul

e G

: U

nit

verif

icat

ion

Mod

ule

H:

y as

sura

nce

EN

ISO

900

1:20

00 (4

)

Man

ufac

ture

r M

anuf

actu

rer s

ubm

its to

not

ified

bod

y M

anuf

actu

rer

Man

ufac

ture

r

> K

eeps

tech

nica

l doc

umen

tatio

n at

th

e di

spos

al o

f nat

iona

l aut

horit

ies

> Te

chni

cal d

ocum

enta

tion

> S

uppo

rting

evi

denc

e fo

r the

ade

quac

y of

the

tech

nica

l des

ign

solu

tion

> S

peci

men

(s),

repr

esen

tativ

e of

the

prod

uctio

n en

visa

ged,

as

requ

ired

> S

ubm

its te

chni

cal

docu

men

tatio

n >

Ope

rate

s an

app

rove

d qu

ality

sy

stem

for d

esig

n

> S

ubm

its te

chni

cal

docu

men

tatio

n

Not

ified

Bod

y

> C

arrie

s ou

t sur

veilla

nce

of th

e qu

ality

sys

tem

Not

ified

Bod

y

> A

scer

tain

s co

nfor

mity

with

ess

entia

l re

quire

men

ts

> E

xam

ines

tech

nica

l doc

umen

tatio

n an

d su

ppor

ting

evid

ence

to a

sses

s ad

equa

cy o

f th

e te

chni

cal d

esig

n

> Fo

r spe

cim

en(s

): ca

rrie

s ou

t tes

ts, i

f ne

cess

ary

> Is

sues

EC

-type

exa

min

atio

n ce

rtific

ate

Mod

ule

H1

Not

ified

bod

y

> V

erifi

es c

onfo

rmity

of d

esig

n

> Is

sues

EC

-type

exa

min

atio

n ce

rtific

ate

Inte

rnTy

Full

qual

it

22

PRO

DU

CTI

ON

PH

ASE

(4) e

xcep

t for

requ

irem

ents

rela

ting

to c

usto

mer

sat

isfa

ctio

n an

d co

ntin

ual i

mpr

ovem

ent

23

Mod

ule

A

Mod

ule

C:

Con

form

ity to

type

M

odul

e D

: Pr

oduc

tion

qual

ity

assu

ranc

e

Mod

ule

E:

Prod

uct q

ualit

y as

sura

nce

Mod

ule

F:

Prod

uct

verif

icat

ion

Mod

ule

G

Mod

ule

H

EN

ISO

900

1:20

00

(2)

EN

ISO

900

1:20

00

(3)

Man

ufac

ture

r M

anuf

actu

rer

Man

ufac

ture

r M

anuf

actu

rer

Man

ufac

ture

r M

anuf

actu

rer

Man

ufac

ture

r

> D

ecla

res

conf

orm

ity

with

ess

entia

l re

quire

men

ts

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> D

ecla

res

conf

orm

ity

with

app

rove

d ty

pe

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> O

pera

tes

an

appr

oved

qua

lity

syst

em fo

r pr

oduc

tion,

fina

l in

spec

tion

and

test

ing

> D

ecla

res

conf

orm

ity

with

app

rove

d ty

pe

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> O

pera

tes

an

appr

oved

qua

lity

syst

em fo

r fin

al

insp

ectio

n an

d te

stin

g

> D

ecla

res

conf

orm

ity w

ith

appr

oved

type

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> D

ecla

res

conf

orm

ity w

ith

appr

oved

type

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> S

ubm

its p

rodu

ct

> D

ecla

res

conf

orm

ity

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> O

pera

tes

an

appr

oved

QS

for

prod

uctio

n, fi

nal

insp

ectio

n an

d te

stin

g

> D

ecla

res

conf

orm

ity

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

A1:

C

1:

D1:

E1

: F1

: A

ccre

dite

d in

-hou

se

body

or n

otifi

ed b

ody

Acc

redi

ted

in-h

ouse

bo

dy o

r not

ified

bod

y D

ecla

res

conf

orm

ity

to e

ssen

tial

requ

irem

ents

Dec

lare

s co

nfor

mity

to

ess

entia

l re

quire

men

ts

Dec

lare

s co

nfor

mity

to

ess

entia

l re

quire

men

ts

> Te

sts

on s

peci

fic

aspe

cts

of th

e pr

oduc

t (1

)

> Te

sts

on s

peci

fic

aspe

cts

of th

e pr

oduc

t (1

)

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

> Af

fixes

requ

ired

conf

orm

ity m

arki

ng

Not

ified

Bod

y N

otifi

ed B

ody

Not

ified

Bod

y N

otifi

ed B

ody

Not

ified

Bod

y

A2:

> P

rodu

ct c

heck

s at

ra

ndom

inte

rval

(1)

C2:

> P

rodu

ct c

heck

s at

ra

ndom

inte

rval

(1)

> A

ppro

ves

the

QS

> C

arrie

s ou

t su

rvei

llanc

e of

the

QS

> A

ppro

ves

the

QS

> C

arrie

s ou

t su

rvei

llanc

e of

the

QS

> V

erifi

es c

onfo

rmity

to

ess

entia

l re

quire

men

ts

> Is

sues

cer

tific

ate

of

conf

orm

ity

> V

erifi

es

conf

orm

ity

to e

ssen

tial

requ

irem

ents

> Is

sues

cer

tific

ate

of c

onfo

rmity

> C

arrie

s ou

t su

rvei

llanc

e of

the

QS

(1) S

uppl

emen

tary

requ

irem

ents

whi

ch m

ay b

e us

ed in

sec

tora

l leg

isla

tion

(2) e

xcep

t for

sub

-cla

use

7.3

and

requ

irem

ents

rela

ting

to c

usto

mer

sat

isfa

ctio

n an

d co

ntin

ual i

mpr

ovem

ent

(3) e

xcep

t for

sub

-cla

uses

7.1

, 7.2

.3, 7

.3, 7

.4, 7

.5.1

, 7.5

.2, 7

.5.3

and

requ

irem

ents

rela

ting

to c

usto

mer

sat

isfa

ctio

n an

d co

ntin

ual i

mpr

ovem

ent

Further information on the modules: (Full text of the modules is provided in Annex II of the Decision)

Module A: Internal production control, covering internal design and production control. This module does not require a notified body to take action. Manufacturer must provide technical documentation which makes it possible to assess the product’s conformity to the essential requirements of the directive. The documentation should also contain a general description of the product, conceptual design, manufacturing drawings and schemes of components, sub-assemblies etc. Manufacturer ensures that the manufacturing process and its monitoring is such that the products comply with the technical documentation, and applies CE marking to each product that meets the applicable requirements of the directive. Manufacturer provides a written declaration of conformity for a product model and keeps it together with technical documentation.

Module A1: internal production control plus supervised product testing. This is similar to module A, but used where additional assurance is required due to certain risks and a notified body or an accredited in-house body carries out one or more tests on each product. The manufacturer affixes the notified body’s identification number to follow the CE marking.

Module A2: internal production control plus supervised product checks at random intervals. This is similar to module A, but product checks are at random intervals in order to verify the quality of internal checks of the product and taking account of technological complexity of the products. In addition, an adequate sample of the final products is examined and appropriate tests as identified by standards or technical specifications are carried out to check conformity with essential requirements. The manufacturer affixes the notified body identification number to follow the CE marking.

Module B: EC type-examination, covering the design phase and is followed by a module providing for assessment in the production phase. The manufacturer ensures there is technical documentation regarding the design, manufacture and operation of the product. This is submitted to the notified body for the adequacy of the technical design solution and product specimens. The notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the requirements of the directive. This is done by examination of the specimen of critical parts of the products; or assessment of the design of the product through examination of the specimen, technical documentation and supporting evidence; or assessment of the design of the product through examination of technical documentation and supporting evidence only. The notified body issues an EC type-examination certificate.

Module C: Conformity to type based on internal production control, covering the production phase and follows module B. This module does not require a notified body to take action. Manufacturer takes measures necessary so that the manufacturing process and its monitoring is in compliance of the products with the approved type described in the

24

EC type-examination certificate and essential requirements of the directive that apply to them. Affixes CE marking to each product and draws up written declaration of conformity which declares that the products are in conformity with the EC type-examination certificate.

Module C1: Conformity to type based on internal production control plus supervised product testing. Module C2: Conformity to type based on internal production control plus supervised product checks at random interval. Modules C1 and C2 are similar modules to A1 and A2, but the conformity assessment procedures declare that the products are in conformity with the type described in the EC type-examination certificate and satisfy the requirements of the directive that apply to them.

Module D: Conformity to type based on quality assurance of the production process, covering the production phase and follows module B. This module is similar module C, but it is based on quality assurance standard, with the intervention of a notified body that is responsible for approving and controlling the quality system for production, final product inspection and testing set up by the manufacturer. The manufacturer is required to operate an approved quality assurance system for production, final product inspection and testing; declares conformity with approved type and affixes CE marking. The notified body assesses the quality system and carries of surveillance of the manufacturer by means of periodic visits.

Module D1: Quality assurance of the production process. Module D1 is similar to D, but additionally requires the manufacturer to establish technical documentation as regards the design, manufacture and operation of the product.

Module E: Conformity to type based on product quality assurance. Module E is similar to module D, but it requires the manufacturer to operate an approved quality system for final product inspection and testing. The notified body is responsible for approving and controlling the quality system for final product inspection and testing set up by the manufacturer.

Module E1: Quality assurance of final product inspection and testing. This module is similar to module D1, but it requires the manufacturer to operate an approved quality system for final product inspection and testing.

Module F: Conformity to type based on product verification, covering the production phase and follows module B. Where examinations and tests are used to check the conformity of the products with essential requirements, the notified body will either test every product or test products on a statistical basis. If statistical verification is used, the manufacturer takes measures necessary to ensure that the manufacturing process and its monitoring ensure the homogeneity of each lot produced. The manufacturer attests

25

that the products are in conformity with the type as described in the EC type-examination certificate, draws up a declaration of conformity and affixes CE marking followed by the identification number of the notified body.

Module F1: Conformity based on product verification. This module is similar to module F, but additionally requires the manufacturer to produce technical documentation regarding the design, manufacture and operation of the product.

Module G: Conformity based on unit verification, covering the design and production phases. The manufacturer produces technical documentation regarding the design, manufacture and operation of the product and declares that the product conforms to the applicable requirements. The notified body examines individual product and ensures its conformity with essential requirements, and issues a certificate of conformity for the tests carried out. The manufacturer draws up a declaration of conformity and affixes CE marking followed by the identification number of the notified body.

Module H: Conformity based on full quality assurance, covering the design and production phases. The conformity is based on the manufacturer operating a full quality assurance system from the design stage to manufacture and final product inspection and testing including the drawing up of technical documentation. The notified body assess the quality system to determine whether it meets applicable requirements. The manufacturer draws up a declaration of conformity and affixes CE marking followed by the identification number of the notified body.

Module H1: Conformity based on full quality assurance plus design examination. This module is similar to H, but requires a notified body to examine the technical design of the product to assess conformity with applicable requirements and issue design examination certificate.

26

Annex D: European Commission document on the differences between conformity assessment modules as laid down in New Approach (Decision 93/465/EEC - old modules) and as laid down in the New Legal Framework (Decision 768/2008/EC - new modules)

Note: the following comparison and detailed analysis in this Annex is a draft written by the European Commission and it is not the final version. {DIUS will update its guidance in due course to include the final version.)

1. Main differences between old modules (as laid down in Decision 93/465/EEC) and new ones (as laid down in Decision 768/2008/EC of the New Legal Framework)

• The new modules A1 and A2 replace the two existing versions of the old module Aa which provides for additional provisions containing supplementary requirements. New modules C1 and C2 are intended to substitute the two options with possible supplementary requirements laid down in the old module C.

The new modules A1, A2, C1 and C2 lay down an additional option for the legislator: the use of an accredited in-house body. In the mentioned modules, the manufacturer could either carry out tests and product checks through and under the responsibility of a third-party (notified body chosen by the manufacturer), as is done currently, or to implement them by an accredited body that forms a part of manufacturer’s organisation. Under modules A2, C2 product checks are carried out at random intervals

Quite often, manufacturers manage very well equipped testing laboratories or premises and their competence is sometimes higher than the abilities of certain notified bodies. Therefore the reliability of the tests and the level of safety could be even improved in this way. However, in this case the in-house body must be accredited. By allowing in-house assessment, the costs in administration and double testing would be reduced, which should result in reductions of the final price for users and consumers. It is necessary to stress that a specific sectoral legislative instrument remains free to require the use of an accredited third party where this is felt necessary.

• Module B tackles the need for greater flexibility to be provided for, through the extension of the concept of type examination to include the options of examining only the technical documentation and/or critical parts of the specimen. This concept is based on the example of the Measuring Instruments Directive and is designed to provide sufficient flexibility and to recognise relevant practice where the examination of the complete specimen “representative of the production envisaged” is either not economically viable or not necessary, such as for well-known products applying standard technology. In this context, type examination may be carried out in three manners:

- either through examination of a specimen, representative of the production envisaged, of the complete product (production type as exists in old module B);

27

- or through assessment of the technical design of the product through examination of the technical documentation and supporting evidence plus examination of specimens for one or more critical parts of the product (combination of production type and design type –introduced in the new module B);

- or through assessment of the technical design of the product requiring the examination of the technical documentation and supporting evidence, without examination of a specimen (design type–introduced in the new module B).

The inclusion of the proposed design examination module in this way also avoids increasing further the number of modules and their variants

• The possibility of using modules D, E and F not in combination with module B, but on their own (for example, for certain products of simple design) was already given in the footnotes to old modules D, E and F – those options now become modules D1, E1 and F1.

The new modules D1, E1 and F1 provide for the possibility of using the advantages of modules D, E and F respectively, without the necessity of recurring to type examination (module B) in the design phase. In the case of products of simple design, but complicated production/manufacturing, the examination of the technical documentation in order to check the design, instead of an EC-type examination, reduces also burdens on manufactures as well as costs.

• Module H1 supersede the supplementary option “design examination” that figures in old module H.

In the case of the new module H1, when the manufacturer operates a full quality assurance system, but the verification of the conformity of design and the issuance of EC design examination certificate by a notified body is necessary, it is ensured that the manufacturer undergoes only once the control of the design phase and the production phase. That would not be the case of a combination of other seemingly appropriate modules or procedures, such as B + H, when the design phase would be evaluated twice. In both modules H, H1 product design is examined; however module H1 goes beyond H, as the design examination leads (upon positive assessment by the notified body) to the issuing of an EC-type examination certificate

• SMEs specificities are taken into account during the implementation of the new modules in relation to administrative burdens. In this respect recital (50) of the Decision states that, rather than providing for general exceptions and derogations for such enterprises, which might imply that they or their products are second-rate or sub-quality, Community sectoral legislation should provide for the characteristics of such enterprises to be taken into account:

(a) in setting the rules for the selection and implementation of the most appropriate conformity-assessment procedures

28

(b) concerning the obligations placed on conformity-assessment bodies to operate in a proportionate manner in relation to the size of undertakings.

Furthermore Art 4.4 of the Decision provides that for custom-made products and small series production, the technical and administrative conditions relating to conformity-assessment procedures shall be alleviated.

• Old modules require from the manufacturer to ensure and declare that the products concerned satisfy the requirements of the directive that apply to them. New modules require from the manufacturer to ensure and declare on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument (not only directive) that apply to them.

Additionally new modules require explicitly that a copy of the declaration of conformity must be available to the relevant authorities upon request.

• Under new modules the authorised representative, if any, must be established within the EU.

Some old modules state that where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market. With the new text this provision has become obsolete and been deleted as art R3.1, R1.4 of the Decision states that manufacturers may appoint, by a written mandate, any natural or legal person established within the Community, ("the authorised representative" – see its definition under art R1.4), to act on their behalf for specified tasks with regard to the obligations of manufacturers.

For sake of legal certainty, new modules specify that the authorised representative may fulfil manufacturer’s obligations, only if this is specified in the mandate. In modules where a quality system is required the role of the authorised representative is extended as he is allowed to lodge the application for the examination of the quality system.

• In the new modules, there is no reference to CE marking, so that they may be used also in areas where CE marking is not foreseen. In this respect, new modules stipulate that the manufacturer must affix the required conformity marking set out in the legislative instrument.

• All footnotes in the old modules have been moved out and transferred to the text. These footnotes provided either for additional information that is an integral part of the text of the modules or instructions for the sectoral legislator that have their place at the main text of the Decision. This has been done for the sake of clarity and in order for the sectoral legislator to be able to make use of the new modules by just referring to them (this is made possible only if the text of the modules is “instructions-free”) and without needing to copy them. More specifically:

The text of the footnotes in the old modules referring to the content of the technical documentation has been for the sake of clarity reformulated and moved to the main text of the new modules. The new modules acknowledge the fact that

29

technical specifications (published in the Official Journal of the EU) other than harmonised standards may be applied by the manufacturer. Thus term “harmonised standards” has been replaced by the term “harmonised standards and/or other relevant technical specifications published in the Official Journal of the EU”. In case where these harmonised standards and/or other technical specifications have been partly applied, the new text requires that technical documentation specifies the parts that have been applied.

The text of the footnotes of the old modules referring to the parameters of the modules the sectoral legislator may modify has been for the sake of clarity reformulated and moved under art. 4.5. Thus the legislator may:

(a) regarding technical documentation, require information additional to that which is already stipulated in the modules;

(b) regarding the time for which span that the manufacturer and/or notified body are obliged to keep any kind of documentation, alter the period stipulated in the modules;

(c) specify the manufacturer's choice as to whether , if the tests are carried out either by an accredited in-house body or under the responsibility of a notified body, chosen by the manufacturer;

(d) where product verification is performed, specify the manufacturer's choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, either by examination and testing of every product, or by examination and testing of the products on a statistical basis;

(e) provide for the EC type examination certificate to have a period of validity;

(f) regarding the EC type examination certificate, specify relevant information for conformity-assessment and in service control to be included in the certificate or its annexes;

(g) provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;

(h) if the notified body carries out periodical audits, specify their frequency.

The text of the footnotes of the old modules referring to the provisions of the legislation that are necessary for the implementation of the modules has been for the sake of clarity reformulated and moved under art. 4.6. Thus the legislator must:

(a) where product checks and/or verification are performed, determine the products concerned, the appropriate tests, the adequate sampling schemes, the operational characteristics of the statistical method to be applied and the corresponding action to be taken by the notified body and/or the manufacturer;

30

(b) where EC type examination is performed, determine the appropriate manner (design type, production type, design and production type) and the specimens required.

• An appeal procedure against decisions of the notified body was foreseen only in a part of the old modules. In the new text this provision, wherever existed (module B) has been moved under art 4.7, so that it applies to all modules.

• New modules defined the obligations of the manufacturer and the notified body more clearly than old ones. For example regarding notified bodies, new modules stipulate clearly:

(a) the obligation of the auditing team to have knowledge of the applicable requirements of the legislative instrument

(b) the information obligation of the body towards not only other bodies (as stipulated in the old modules) but also its notifying authorities.

Regarding manufacturers the new text clarifies their obligation to inform notified bodies of any change (not only update as in the old modules) in the quality system that may affect the conformity of the product.

31

Detailed Analysis

Old Module A New Module A A1 states that the manufacturer ensures and declares that the products concerned satisfy the requirements of the directive that apply to them

A.1, A1.1, A2.1 state that the manufacturer ensures and declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.

A.1 states that the manufacturer draws up a written declaration of conformity

A.4.2, A1.5.2, A2.5.2 require that the manufacturer shall draw up a written declaration of conformity for a product model. The declaration of conformity shall identify the product for which it has been drawn up.

A.2 states that where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

No need for such provision – Art R1.4, R3.1 of the decision state that manufacturers may appoint, by a written mandate, any natural or legal person established within the Community, ("the authorised representative"), to act on their behalf for specified tasks with regard to the obligations of manufacturers

A.1 states that the manufacturer must affix the CE marking to each product

A.4.1, A1.5.1, A2.5.1 states that the manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument

A.1, A.2, A.4 state that instead the manufacturer its authorised representative may affix the CE marking, draw up a declaration of conformity and keep the documentation (technical documentation, copy of the declaration of conformity)

A.5 states that the manufacturer's obligations regarding conformity marking, keeping the documentation declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

A.2 states that the manufacturer must keep the declaration of conformity for a period ending at least 10 years after the last product has been manufactured

A.4.2, A1.5.2, A.2.5.2 state that the manufacturer shall keep the declaration of conformity together with the technical documentation at the disposal of the national authorities for ten years after the product has been placed on the market

A.2.footnote2 states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

32

A.2.footnote3 states that the content of the technical documentation shall be laid down directive by directive in accordance with the products concerned. For example, the documentation must contain so far as relevant for assessment:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports

A.2, A1.2, A2.2 state that the technical documentation shall contain, wherever applicable, at least the following elements:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

Art 4.5.a states that regarding technical documentation, the legislator may require information additional to that which is already stipulated in the modules

33

Old Module Aa (additional to old module A)

New Modules A1, A2 (additional to new module A)

Both supervised product testing and supervised product checks at random intervals are tackled together by the old module Aa

Supervised product testing is tackled by new module A1 and supervised product checks at random intervals is tackled by new module A2

The possibility of using an in-house accredited body does not exist

A1.4, A2.4 allow the use of an in-house accredited body. Art 4.5.c states that the legislator may specify the manufacturer's choice as to whether , if the tests are carried out either by an accredited in-house body or under the responsibility of a notified body, chosen by the manufacturer

Aa states that tests are carried out A1.4 states that tests are carried out in order to verify conformity with the corresponding requirements of the legislative instrument

A2.4 states that tests are carried out in order to verify the quality of the internal checks of the product, taking into account inter alia the technological complexity of the products and the quantity of production.

Aa does not specify how random intervals are defined

A2.4 states that random intervals are defined by the body

Aa states that product checking must include aspects such as for example the statistical method to be applied, the sampling plan with its operational characteristics, etc

Art 4.6.a states that the appropriate tests, the adequate sampling schemes and the corresponding action to be taken by the body and/or the manufacturer shall be defined by the specific legislative instrument.

34

Old Module B New Module B B.1 states that the notified body attest that a specimen meets the provision of the directive that apply to it

B.1 states that the attest that a specimen meets the provisions of the legislative instrument that apply to it

B.1 specifies that EC-type examination is done only by examining a specimen, representative of the production envisaged (production type examination)

B.2 does not require that manufacturers application must include also supporting evidence for the adequacy of the technical design

B.2 extends of the concept of type examination to include two additional options:

- assessment of the technical design of the product requiring the examination of the technical documentation and supporting evidence, without examination of a specimen (design type examination)

- assessment of the technical design of the product through examination of technical documentation and supporting evidence plus examination of specimens for one or more critical parts of the product (combination of design- and product-type examination). In this respect, B.3 requires that manufacturers application must include also supporting a specimen representative and evidence for the adequacy of the technical design (not required in the old module B)

Art 4.6.b specifies that where EC type examination is performed, the legislator must determine the appropriate manner (design type, production type, design and production type) and the specimens required.

B does not oblige explicitly the notified body to issue an evaluation report

B.5 obliges the notified body to issue an evaluation report (prior to its decision to issue or not the examination certificate to the manufacturer)

B.7 obliges the notified body to provide information other notified bodies

B.8 obliges the notified body to provide information other notified bodies and its notifying authorities

B does not oblige the notified body to keep itself appraised of any changes of the generally acknowledged state of the art which may indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument,

B.7 obliges the notified body to keep itself appraised of any changes of the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigations. If so, according to B.7 the notified body shall inform the manufacturer accordingly.

35

B.9 states that where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

No need for such provision – Art R1.4, R3.1 of the decision states that manufacturers may appoint, by a written mandate, any natural or legal person established within the Community, ("the authorised representative"), to act on their behalf for specified tasks with regard to the obligations of manufacturers

B.2 states that instead the manufacturer its authorised representative may lodge the application for the EC-type examination and keep the documentation (technical documentation, EC-type certificates)

B.10 (referring to B.7, B.9) states that the manufacturer's obligations regarding keeping the documentation and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

B.5 states that provision must be made for an appeals procedure

Art 4.7 states that an appeal procedure against decisions of the notified body shall be available

B.6 states that the applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved product which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the product.

B.7 states that the manufacturer shall inform the notified body that holds the technical documentation relating to the EC-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential requirements of the legislative instrument or the conditions for validity of the certificate.

B.3.footnote6 states that the content of the technical documentation shall be laid down directive by directive in accordance with the products concerned. For example, the documentation must contain so far as relevant for assessment:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards have not been applied,

B.3 states that the technical documentation shall contain, wherever applicable, at least the following elements:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet

36

- results of design calculations made, examinations carried out, etc.,

- test reports

the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

- a specimen representative and supporting evidence for the adequacy of the technical design (not required in the old module B). This supporting evidence shall mention any relevant documents that have been applied, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

Art 4.5.a states that regarding technical documentation, the legislator may require information additional to that which is already stipulated in the modules

B.5.footnote7 states that the specific directives may provide for the certificate to have a period of validity

Art 4.5.e states that the legislator may provide for the EC type examination certificate to have a period of validity;

B does not tackle the issue of in-service control

Art 4.5.f states that regarding the EC type examination certificate, the legislator may specify relevant information for conformity-assessment and in service control to be included in the certificate or its annexes;

B.7.footnote8 states that the specific directives may provide for different arrangements regarding the obligations of the notified body to provide information

Art 4.5.g states that the legislator may provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;

B.9 states that the manufacturer must keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least 10 years after the last product has been

B.9 states that the manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the technical documentation for ten years after the product has been placed on the market

37

manufactured B.9.footnote9 states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

38

Old Module C New Modules C, C1, C2 C.1 states that the manufacturer ensures and declares that the products concerned satisfy the requirements of the directive that apply to them

C.1, C1.1, C2.1 state that the manufacturer ensures and declares that the products concerned satisfy the requirements of the legislative instrument that apply to them.

C.1 states that the manufacturer draws up a written declaration of conformity

C.3.2, C1.4.2, C2.4.2 require that the manufacturer shall draw up a written declaration of conformity for a product model. The declaration of conformity shall identify the product model for which it has been drawn up.

Old module C tackles not only the case where no supervised testing/checks are performed but also both cases where supervised product testing and supervised product checks at random intervals are performed.

The case where no supervised testing/checks are performed is tackled by the new module C. Supervised product testing is tackled by new module C1 and supervised product checks at random intervals is tackled by new module C2

The possibility of using an in-house accredited body does not exist

C1.3, C2.3 allow the use of an in-house accredited body.

Art 4.5.c states that the legislator may specify the manufacturer's choice as to whether , if the tests are carried out either by an accredited in-house body or under the responsibility of a notified body, chosen by the manufacturer

C.3 states that tests are carried out C1.3 states that tests are carried out in order to verify conformity with the corresponding requirements of the legislative instrument C2.3 states that tests are carried out in order to verify the quality of the internal checks of the product, taking into account inter alia the technological complexity of the products and the quantity of production.

C does not specify how random intervals are defined

C2.3 states that random intervals are defined by the body

C.3 states that product checking must include aspects such as for example the statistical method to be applied, the sampling plan with its operational characteristics, etc

Art 4.6.a states that the appropriate tests, the adequate sampling schemes and the corresponding action to be taken by the body and/or the manufacturer shall be defined by the specific legislative instrument

C.3 states that where neither the manufacturer nor his authorized representative is established within the

No need for such provision – Art R1.4, R3.1 of the decision states that manufacturers may appoint, by a written mandate, any natural or legal person

39

Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

established within the Community, ("the authorised representative"), to act on their behalf for specified tasks with regard to the obligations of manufacturers

C.1 states that the manufacturer must affix the CE marking to each product

C.3.1, C1.4.1, C2.4.1 state that the manufacturer shall affix the required conformity marking as set out in the legislative instrument to each individual product that is in conformity with the type as described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument

C1, C.3 state that instead the manufacturer its authorised representative may affix the CE marking, draw up a declaration of conformity and keep the documentation (technical documentation, copy of the declaration of conformity)

C.4, C1.5, C2.5 state that the manufacturer's obligations regarding conformity marking, documentation declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

C.3 states that the manufacturer or his authorized representative must keep a copy of the declaration of conformity for a period ending at least 10 years after the last product has been manufactured

C.3.2, C1.4.2, C2.4.2 state that the manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for a period of ten years after the product has been placed on the market

C.3.footnote10 states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

40

Old Module D New Modules D, D1 D.1 states that the manufacturer ensures and declares that the products concerned satisfy the requirements of the directive that apply to them

D.1, D1.1 state that the manufacturer ensures and declares that the products concerned satisfy the requirements of the legislative instrument that apply to them.

When D is used without module B, then according to footnote 12, A.2, A.3 (both concern technical documentation) must be added between points D.1 and D.2 in order to incorporate the need for technical documentation

A.2, A3 state that the content of the technical documentation shall be laid down directive by directive in accordance with the products concerned. For example, the documentation must contain so far as relevant for assessment:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports

This option became now module D1. D1.2, D1.3 (both concern technical documentation) provide for the possibility of using the advantages of the new module D without the necessity of recurring to type examination (module B) in the design phase.

D1.2 states that the technical documentation shall contain, wherever applicable, at least the following elements:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

Art 4.5.a states that regarding technical documentation, the legislator may require

41

information additional to that which is already stipulated in the modules

D.3.1 states that he application of the manufacturer must include:

- all relevant information for the product category envisaged,

- the documentation concerning the quality system,

- if applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate.

D3.1, D1.5.1 state that he application of the manufacturer must include:

- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition (not required explicitly by the old module D);

- a written declaration that the same application has not been lodged with any other notified body (not required by the old module D);

- all relevant information for the product category envisaged (required by the old module D also);

- the documentation concerning the quality system (required by the old module D also);

- the technical documentation of the approved type and a copy of the EC-type examination certificate in case of new module D (required by the old module D also) or the technical documentation for the design, manufacture and operation of the product in case of new module D1 (see D1.2 - not existed in the old module D).

D.3.2 states that the quality system documentation must permit a common understanding of the quality programmes, plan, manuals and records.

D.3.2 and D1.5.2 state that the quality system documentation must permit a consistent interpretation of the quality programmes, plan, manuals and records.

D.3.3 states that the auditing team must have at least one member with experience of evaluation in the product technology concerned.

D.3.3, D1.5.3 state that in addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of the legislative instrument. D.3.3, D1.5.3 state also that the auditing team shall review the technical documentation

D.3.3 states that the notified body presumes conformity with these requirements in respect of quality systems that implement the relevant harmonized standard

D.3.3., D1.5.3 state that the notified body shall presume conformity with these requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant

42

harmonised standard and/or technical specifications.

D.1 states that the manufacturer draws up a written declaration of conformity

D.5.2, D1.7.2 require that the manufacturer shall draw up a written declaration of conformity for a product model. The declaration of conformity shall identify the product model for which it has been drawn up.

D.6 states that each notified body must give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn

D.7, D1.9 state that each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or withdrawn, and, upon request, of the quality system approvals which it has issued. D.7, D1.9 state also that each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted

D.1 states that the manufacturer must affix the CE marking to each product. The same article states that the CE marking (affixed by the manufacturer) must be accompanied by the identification symbol of the notified body

D.5.1, states that the manufacturer shall affix the required conformity marking set out in the legislative instrument and, under the responsibility of the notified body the latter’s identification number to each individual product that is in conformity with the type as described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

D1.7.1 states that the manufacturer shall affix the required conformity marking and, under the responsibility of the notified body the latter’s identification number to each individual product that satisfies the applicable requirements of the legislative instrument (no EC-type under D1).

D.1, D3.4 state that instead the manufacturer its authorised representative may affix the CE marking, draw up a declaration of conformity and keep the notified body informed about updates in the quality system

D.8, D1.10, state that the manufacturer's obligations regarding conformity marking, keeping the documentation declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

D.8, D1.10 extend also the role authorised representative by allowing him to lodge the application for the examination of the quality

43

system.

D.3.4 states that the manufacturer shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.

D.3.5, D1.5.5 state that the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system.

D.4.3.footnote14 stets that n the specific directives, the frequency of the audits may be specified.

Art 4.5.h states that if the notified body carries out periodical audits, the legislator may specify their frequency.

D.5 states that the manufacturer must, keep all relevant documentation for a period ending at least 10 years after the last product has been manufactured

D.5.2, D.6, D1.7.2, D1.8 state that the manufacturer must keep the declaration of conformity and the documentation for a period ending at least ten years after the product has been placed on the market

D.5.footnote15. states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

D.6.footnote16 states that the specific directives may provide for different arrangements regarding the obligations of the notified body to provide information

Art 4.5.g states that the legislator may provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;

44

Old Module E New Modules E, E1 E.1 states that the manufacturer ensures and declares that the products concerned satisfy the requirements of the directive that apply to them

E.1, E1.1 state that the manufacturer ensures and declares that the products concerned satisfy the requirements of the legislative instrument that apply to them.

When E is used without module B, then according to footnote 17, A.2, A.3 (both concern technical documentation) must be added between points E.1 and E.2 in order to incorporate the need for technical documentation

A.2, A3 state that the content of the technical documentation shall be laid down directive by directive in accordance with the products concerned. For example, the documentation must contain so far as relevant for assessment:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports

This option became now module E1. E1.2, E1.3 (both concern technical documentation) provide for the possibility of using the advantages of the new module E without the necessity of recurring to type examination (module B) in the design phase.

E1.2 states that the technical documentation shall contain, wherever applicable, at least the following elements:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

Art 4.5.a states that regarding technical

45

documentation, the legislator may require information additional to that which is already stipulated in the modules

E.3.1 states that he application of the manufacturer must include:

- all relevant information for the product category envisaged,

- the documentation concerning the quality system,

- if applicable, the technical documentation of the approved type and a copy of the EC type-examination certificate.

E3.1, E1.5.1 state that he application of the manufacturer must include:

- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition (not required explicitly by the old module E);

- a written declaration that the same application has not been lodged with any other notified body (not required by the old module E);

- all relevant information for the product category envisaged (required by the old module E also);

- the documentation concerning the quality system (required by the old module E also);

- the technical documentation of the approved type and a copy of the EC-type examination certificate in case of new module E (required by the old module E also )or the technical documentation for the design, manufacture and operation of the product in case of new module E1 (see E1.2 - not existed in the old module E) .

E.3.2 states that the quality system documentation must permit a common understanding of the quality programmes, plan, manuals and records.

E.3.2 and E1.5.2 state that the quality system documentation must permit a consistent interpretation of the quality programmes, plan, manuals and records.

E.3.3 states that the auditing team must have at least one member with experience of evaluation in the product technology concerned.

E.3.3, E1.5.3 state that in addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of the legislative instrument. E.3.3, E1.5.3 state also that the auditing team shall review the technical documentation

E.3.3 states that the notified body presumes conformity with these requirements in respect of quality systems that implement the relevant harmonized standard

E.3.3., E1.5.3 state that the notified body shall presume conformity with these requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant

46

harmonised standard and/or technical specifications.

E.1 states that the manufacturer draws up a written declaration of conformity

E.5.2, E1.7.2 require that the manufacturer shall draw up a written declaration of conformity for a product model. The declaration of conformity shall identify the product model for which it has been drawn up

E.6 states that each notified body must give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn

E.7, E1.9 state that each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or withdrawn, and, upon request, of the quality system approvals which it has issued.

E.7, E1.9 state also that each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted

E.1 states that the manufacturer must affix the CE marking to each product. The same article states that the CE marking (affixed by the manufacturer) must be accompanied by the identification symbol of the notified body

E.5.1, states that the manufacturer shall affix the required conformity marking set out in the legislative instrument and, under the responsibility of the notified body the latter’s identification number to each individual product that is in conformity with the type as described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

E1.7.1 states that the manufacturer shall affix the required conformity marking and, under the responsibility of the notified body the latter’s identification number to each individual product that satisfies the applicable requirements of the legislative instrument (no EC-type under E1).

E.1, E.3.4 state that instead the manufacturer its authorised representative may affix the CE marking, draw up a declaration of conformity and keep the notified body informed about updates in the quality system

E.8, E1.10, state that the manufacturer's obligations regarding conformity marking, keeping the documentation, declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

E.8, E1.10 extend also the role authorised representative by allowing him to lodge the

47

application for the examination of the quality system.

E.3.4 states that the manufacturer shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.

E.3.5, E1.5.5 state that the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system.

E.4.3.footnote19 stets that n the specific directives, the frequency of the audits may be specified.

Art 4.5.h states that if the notified body carries out periodical audits, the legislator may specify their frequency.

E.5 states that the manufacturer must, keep all relevant documentation for a period ending at least 10 years after the last product has been manufactured

E.5.2, E.6, E1.7.2, E1.8 state that the manufacturer must keep the declaration of conformity and the documentation for a period ending at least ten years after the product has been placed on the market

E.5.footnote20. states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

E.6.footnote21 states that the specific directives may provide for different arrangements regarding the obligations of the notified body to provide information

Art 4.5.g states that the legislator may provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities

48

Old Module F New Modules F, F1 F.1 states that the manufacturer ensures and declares that the products satisfy the requirements of the directive that apply to them

F.1, F1.1 state that the manufacturer ensures and declares that the products satisfy the requirements of the legislative instrument that apply to them.

When F is used without module B, then according to footnote 22, A.2, A.3 (both concern technical documentation) must be added between points F.1 and F.2 in order to incorporate the need for technical documentation.

A.2, A3 state that the content of the technical documentation shall be laid down directive by directive in accordance with the products concerned. For example, the documentation must contain so far as relevant for assessment:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports

This option became now module F1. F1.2 (technical documentation), F1.3 (manufacturing) provide for the possibility of using the advantages of the new module F without the necessity of recurring to type examination (module B) in the design phase.

F1.2 states that the technical documentation shall contain, wherever applicable, at least the following elements:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

Art 4.5.a states that regarding technical documentation, the legislator may require

49

information additional to that which is already stipulated in the modules

F.4.1 (testing of every product), F.5.2 (statistical verification) states that all products must be examined and appropriate tests must be done as set out in the relevant standard(s)

F.4.1 (testing of every product), F1.5.1 (testing of every product), F.5.2 (statistical verification), F1.6.2 (statistical verification) state that all products shall be examined and appropriate tests must be done, as set out in the relevant harmonised standards and/or technical specifications.

The above articles state also that in the absence of harmonised standards, the notified body decides on the appropriate tests to be carried out

F.4.2 (testing of every product) states that the notified body must affix or cause to be affixed, its identification symbol to each approved product

F.5.4 (statistical verification) states that the manufacturer may, under the responsibility of the notified body, affix the latter's identification symbol during the manufacturing process.

F.4.2 (testing of every product), F1.5.2 (testing of every product), state that the notified body shall affix its identification number to each approved product or have it affixed under its responsibility.

F.6.1, F.7 (both testing of every product and statistical verification), F1.7.1, F1.8 (both testing of every product and statistical verification) state that, the manufacturer may affix the notified body’s identification number to the products, under the responsibility of the notified body (also during the manufacturing process if agreed by the notified body).

F.2 states that the manufacturer draws up a written declaration of conformity

F.6.2, F1.7.2 require that the manufacturer shall draw up a written declaration of conformity for a product model. The declaration of conformity shall identify the product model for which it has been drawn up.

F.2 states that the manufacturer shall affix the CE marking to each product

F.6.1, states that the manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that is in conformity with the type as described in the EC-type examination certificate and satisfies the applicable requirements of the legislative instrument.

F1.7.1 states that the manufacturer shall affix the required conformity marking to each individual product that satisfies the applicable requirements of the legislative instrument (no EC-type under F1).

50

F.3a, F.4.3 (testing of every product), F5.5 (statistical verification) state that instead the manufacturer its authorised representative may keep the certificate/declaration of conformity.

According to F.2, only the manufacturer shall affix the CE marking and draw up a declaration of conformity.

F.8, F1.9 state that the manufacturer's obligations regarding conformity marking, keeping the documentation declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

F.8, F1.9 extend also the role authorised representative by allowing him to affix the required conformity marking.

F.3.footnote23 states that the manufacturer's discretion may be limited in the specific directives as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, either by examination and testing of every product, or by examination and testing of the products on a statistical basis

Art 4.5.d states that where product verification is performed, the legislator may specify the manufacturer's choice as to whether the examinations and tests to check the conformity of the products with the appropriate requirements will be carried out, either by examination and testing of every product, or by examination and testing of the products on a statistical basis

F.3a states that the manufacturer must keep the declaration of conformity for a period ending at least 10 years after the last product has been manufactured

F.6.2, F1.7.2 state that the manufacturer must keep the declaration of conformity for a period ending at least 10 years after the product has been placed on the market

F1.2 states that that the manufacturer shall keep the technical documentation for ten years after the product has been placed on the market

F.3a.footnote24. states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

51

Old Module G New Module G G.1 states that the manufacturer ensures and declares that the product conforms to the requirements of the directive that apply

G.1 states that the manufacturer ensures and declares that the product conforms to the requirements of the legislative instrument that apply

G.1 states that manufacturer draws up a written declaration of conformity

G.5.2 requires that the manufacturer shall draw up a written declaration of conformity for a product. The declaration of conformity shall identify the product for which it has been drawn up

There are no provisions regarding manufacturer’s obligation to take all measures necessary in order that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the legislative instrument.

G.3 obliges the manufacturer to take all measures necessary to ensure that the manufacturing process and its monitoring ensure conformity of the manufactured product with the applicable requirements of the legislative instrument.

There is no clear obligation of the manufacturer to keep any documentation (technical documentation or copy of the declaration of conformity)

G.2, G.4, G.5.2 oblige the manufacturer to keep the technical documentation, the certificate of conformity and the copy of the declaration of conformity at the disposal of the relevant national authorities for a period of 10 years after the product has been placed on the market.

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

G.2 states that the notified body affixes or causes to be affixed its identification number on the approved product

G.4, G.5.1 state that the notified body shall affix its identification number to the approved product, or have it affixed under its responsibility by the manufacturer (also during the verification process if agreed by the notified body)

G.2 states that all products must be examined and appropriate tests must be done as set out in the relevant standard(s)

G.4 states that products shall be examined and appropriate tests must be done, as set out in the relevant harmonised standards and/or technical specifications.

G.4 states also that in the absence of harmonised standards and/or technical specifications, the notified body decides on the appropriate tests to be carried out

52

G.1 states that the manufacturer must affix the CE marking to the product

G.5.1, states that the manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual product that satisfies the applicable requirements of the legislative instrument.

G.1 states that instead the manufacturer its authorised representative may affix the CE marking and draw up a declaration of conformity

G.6 states that the manufacturer's obligations regarding conformity marking, keeping the documentation, declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

G.6 extends the role authorised representative by allowing him to establish and keep the technical documentation.

G.3.footnote25 states that the content of the technical documentation shall be laid down directive by directive in accordance with the products concerned. For example, the documentation must contain so far as relevant for assessment:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,

- a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards have not been applied,

- results of design calculations made, examinations carried out, etc.,

G.2 states that the technical documentation shall contain, wherever applicable, at least the following elements:

- a general description of the product,

- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

53

- test reports - test reports.

Art 4.5.a states that regarding technical documentation, the legislator may require information additional to that which is already stipulated in the modules

54

Old Module H New Modules H, H1 H.1 states that the manufacturer ensures and declares that the products concerned satisfy the requirements of the directive that apply to them

H.1, H1.1 state that the manufacturer ensures and declares that the products concerned satisfy the requirements of the legislative instrument that apply to them.

H.3.1 states that he application of the manufacturer for the assessment of his quality system must include:

- all relevant information for the product category envisaged,

- the documentation concerning the quality system,

H3.1, H1.3.1 state that he application of the manufacturer for the assessment of his quality system must include:

- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition (not required explicitly by the old module H);

- a written declaration that the same application has not been lodged with any other notified body (not required by the old module H);

- the technical documentation as described in the legislative instrument, for one model of each category of products intended to be manufactured in case of H or all relevant information for the product category envisaged in case of H1 (the latter is required by the old module H also);

- oncerning the quality system (required by the old module H also);

H does not provide instructions regarding the content of the technical documentation

H.3.1, H1.4.2 state that states that the technical documentation shall contain, wherever applicable, at least the following elements: - a general description of the product,

-conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

- a list of the harmonised standards and/or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the legislative instrument where those harmonised standards

the documentation c

55

have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

- (only for H1) the supporting evidence for the adequacy of the technical design. dence shall mention any documents that have been applied, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility Art 4.5.a states that regarding technical documentation, the legislator may require information additional to that which is already stipulated in the modules Note: under H1 technical documentation of the product is required already for the EC-type examination, while under H technical documentation of the product is required for the assessment of quality system

H.3.3 states that the notified body presumes compliance with these requirements in respect of quality systems that implement the relevant harmonized standard

H.3.3, H1.3.3 states that the notified body presumes conformity with these requirements in respect of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard and/or technical specification.

H.3.3 states that the auditing team must have at least one member with experience of evaluation in the product technology concerned.

H.3.3, H1.3.3 state that in addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of the legislative instrument.

H3.3 states also that the auditing team shall review the technical documentation. Under H1 an examination of the documentation is part of design

That evi

verification (H1.4)

56

H.1 states that manufacturer draws up a written declaration of conformity

H.5.2, H1.6.2 require that the manufacturer shall draw up a written declaration of conformity for a product model. The declaration of conformity shall identify the product model for which it has been drawn up

H1.6.2 states in addition that the declaration of conformity shall mention the number of the design examination certificate

H.1 states that the manufacturer must affix the CE marking to each product. H.1 states also that the CE marking (affixed by the manufacturer) must be accompanied by the identification symbol of the notified body

H.5.1, H1.6.1 state that the manufacturer shall affix the required conformity marking set out in the legislative instrument and, under the responsibility of the notified body the latter’s identification number to each individual product that satisfies the applicable requirements of the legislative instrument.

H.1, H.3.4 state that instead the manufacturer its authorised representative may affix the CE marking, draw up a declaration of conformity and keep the notified body informed about updates in the quality system

H.8, H1.9 state that the manufacturer's obligations regarding conformity marking, documentation declaration of conformity and providing information may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate

H.8, H1.9 extend also the role authorised representative by allowing him to lodge the application for the examination of the quality system and (only in H1.9) for the EC-type examination

H.3.4 states that the manufacturer shall keep the notified body that has approved the quality system informed of any intended updating of the quality system.

H.3.5, H1.3.5 state that the manufacturer shall keep the notified body that has approved the quality system informed of any intended change of the quality system.

H1.4.4 states that the manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of the legislative instrument or the conditions for validity of the certificate.

Module H includes possible supplementary requirements regarding design examination.

This option became now module H1 (under H1.4 -design verification)

H.Design examination. 2 states that the application of the manufacturer must include

H1.4.2 states that the application of the manufacturer for the examination of the design

57

the technical design specifications, including standards, that have been applied, and the necessary supporting evidence for their adequacy

must include:

- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition (not required explicitly by the old module H);

- a written declaration that the same application has not been lodged with any other notified body (not required by the old module H);

- the technical documentation as described in the legislative instrument (not explicitly required by the old module H).

- the supporting evidence for the adequacy of the technical design (required by the old module H).

H.Design examination. 3 requires that the EC design examination certificate shall contain:

- the conclusions of the examination,

- conditions for its validity,

- the necessary data for identification of the approved design and, if relevant,

- a description of the product's functioning.

H1.4.3 requires that the EC design examination certificate and its annexes shall contain:

- the name and address of the manufacturer,

- the conclusions of the examination,

- conditions (if any) for its validity,

- the necessary data for identification of the approved design,

- all relevant information to allow the conformity of manufactured products to be evaluated with the examined design, and to allow for in-service control, where applicable.

H.Design examination does not stipulate explicitly what happens if the design does not satisfy the applicable requirements (such a provision exists in H.3.4 but only regarding the quality system)

H1.4.3 states that where the design does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

H.Design examination does not oblige the notified body to keep itself appraised of any changes of the generally acknowledged state of the art which may indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument,

H1.4.4 obliges the notified body to keep itself appraised of any changes of the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument and to inform the manufacturer

58

H.Design examination. 5 oblige the notified body to provide information other notified bodies

H.7, H1.3.6 state that each notified body shall inform its notifying authorities of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

H.7, H1.3.6 state each notified body shall inform the other notified bodies of the quality system approvals which it has refused, suspended or withdrawn, and, upon request, of the quality system approvals which it has issued.

For the EC-type examination: H1.4.5 states that each notified body shall inform its notifying authorities about of the EC design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

H1.4.5 states also that each notified body shall inform the other notified bodies about of the EC design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, about of the certificates and/or additions thereto which it has issued

H.4.3.footnote27 stets that n the specific directives, the frequency of the audits may be specified.

Art 4.5.h states that if the notified body carries out periodical audits, the legislator may specify their frequency.

H.5 states that the manufacturer must, keep all relevant documentation for a period ending at least 10 years after the last product has been manufactured

H.5.2, H.6, H1.6.2, H1.7 state that the manufacturer must keep the declaration of conformity and the documentation for a period ending at least ten years after the product has been placed on the market

H1.4.5 (last paragraph) states that the notified shall keep a copy of the EC design examination certificate and the relevant documentation until the expiry of the validity of the certificate.

H1.4.6 stipulates that the manufacturer shall keep a copy of the EC design examination certificate and the relevant documentation for 10 years after

59

the product has been placed on the market

H.5.footnote28. states that the specific directives may alter period manufacturer and/or notified body are obliged to keep any kind of documentation

Art 4.5.b states that regarding the time the manufacturer and/or notified body are obliged to keep any kind of documentation, the legislator may alter the period stipulated in the modules

H.6.footnote29, H.design_examination.5.footonote30 state that the specific directives may provide for different arrangements regarding the obligations of the notified body to provide information

Art 4.5.g states that the legislator may provide for different arrangements regarding the obligations of the notified body to inform its notifying authorities;

60

Annex E: Model structure of the EC Declaration of Conformity

1. No … (unique identification of the product):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer (or installer):

4. Object of the declaration (identification of product allowing traceability. It may

include a photograph, where appropriate):

5. The object of the declaration described above is in conformity with the

relevant Community harmonisation legislation: ………

6. References to the relevant harmonised standards used or references to the

specifications in relation to which conformity is declared:

7. Where applicable, the notified body ... (name, number)… performed …

(description of intervention) … and issued the certificate: ….

8. Additional information:

Signed for and on behalf of: ………………………….

(place and date of issue)

(name, function) (signature)

61

Annex F: Sources of information

UKAS (http://www.ukas.com) documents: Application forms for organisations wishing to be accredited: http://www.ukas.com/information_centre/accreditation_category_forms.asp

Publications that would help organisations wishing to be accredited: http://www.ukas.com/information_centre/publications.asp

European and national standards Copies and information on the relevant standards in the EN 45000 and ISO/IEC 17000 series are available from BSI:

British Standards Institution 389 Chiswick Road London, W4 4AL

Tel: 020 8996 9001 Web: www.bsi-global.com

The UK Regulations The UK Regulations may be obtained from the Office of Public Sector Information by direct download from: http://www.opsi.gov.uk/stat.htm

List of product directives and regulations http://www.berr.gov.uk/sectors/sustainability/regulations/ecdirect/index.html

http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist.html

Official Journal of the European Union The Eur-lex website http://eur-lex.europa.eu/en/index.htm has the Official Journal from 1998 onwards on-line.

The publication of Decision 768/2008/EC and Regulation (EC) No 765/2008 in the OJ can be seen at: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:218:SOM:EN:HTML

62

Guide to the Implementation of Directives Based on New Approach and Global Approach (‘Blue Book’) (This guidance will updated by the Commission in due course) http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

NANDO (New Approach Notified & Designated Organisations) Information System The Commission's on-line database of notified bodies notified by the UK and other Member States:http://ec.europa.eu/enterprise/newapproach/nando/

Review of the New Approach Further information can be found in: http://ec.europa.eu/enterprise/newapproach/review_en.htm

Directive 98/34/EC - laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services: http://ec.europa.eu/enterprise/tris/index_en.htm

European Accreditation (EA) http://www.european-accreditation.org/

European Commission’s standardisation policy http://ec.europa.eu/enterprise/standards_policy/index_en.htm

European Standards Organisations CEN: http://www.cen.eu/cenorm/homepage.htm CENELEC: http://www.cenelec.eu/Cenelec/Homepage.htm ETSI: http://www.etsi.org/website/homepage.aspx

First published February 2009 Department for Innovation, Universities and Skills

http://www.dius.gov.ukURN 208-09-In-on

© Crown Copyright

63