Answers and Resolutions by EK-Med

Conformity Assessment 3.9 B 16

Zentralstelle der Lnder fr Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Sebastianstrae 189 53115 Bonn Germany

Telefon +49 228 97794-0 Fax +49 228 97794-44 E-Mail zlg@zlg.nrw.de Website www.zlg.de

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Certification of OEM Devices

Often identical medical devices are placed on the market under different manufacturers' names, although a single producer makes them. In such cases the company under whose name the device is placed on the market does not control large parts of the devices design and manufacturing process. Dealers or sales organisations who place medical devices on the market under their own name are, however, manufacturers in the meaning of the Medical Devices Directives and must conduct a corresponding conformity assessment procedure regardless of what influence they have on the development and/or production of the devices. In such cases the Notified Body will only be able to audit a few aspects of the conformity assessment procedure selected directly at the manufacturer's premises in the meaning of the Directives.

If Original Equipment Manufacturers (OEM) carry out relevant design or manufacturing steps, the Notified Body must include these steps in the assessment. This arises from the provisions of Medical Devices Directives.

The extent to which the OEM is being involved in the conformity assessment procedure for the private label manufacturer (PLM) is mainly dependent on whether and on which basis certificates exist for the OEM respectively his quality management system or products and by which body these certificates were issued.

The different possible scenarios are described in this document.

1 Definitions The following definitions apply for the following remarks:

Private Label Equivalent to trade name

Private Label Manufacturer (PLM) Company that appears as manufacturer in the meaning of the Medical Devices Directives, but does not itself produce (often also called "quasi manufacturer").

The devices are not modified by the Private Label Manufacturer, or only slightly; normally they are only purchased, stored and sold under his own name.

OEM Original Equipment Manufacturer; Company that produces the finished device for a Private Label Manufacturer and in this case does not appear as the manufacturer in the meaning of the Medical Devices Directives.

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2 Possible scenarios The following are the possible scenarios when certifying OEM devices, i.e. devices sold by a PLM under his own name, but not produced by him:

A OEM is himself also manufacturer in the meaning of the Medical Devices Directives for the relevant device and accordingly certified by a Notified Body under the relevant Directive. Depending on the class of the medical device and on the conformity assessment procedure chosen by the OEM different constellations have to be distinguished:

A 1 The quality assurance system of the OEM has been certified according to Annex II, V or VI, but a product certification according to Annex II (4) or III is not required

A 2 The quality assurance system of the OEM has been certified according to Annex II (3) and his product according to Annex II (4)

A 3 The quality assurance system of the OEM has been certified according to Annex V or VI and his product according to Annex III

A 4 The quality assurance system of the OEM has not been certified, i.e. conformity assessment procedure according to Annex III combined with IV, or VII combined with IV.

B OEM does not operate with respect to this device as manufacturer in the meaning of the Directives and is certified according to EN ISO 13485 : 20031. This certification has to be granted by a body authorised for this product/group of products by an authority competent for the designation of Notified Bodies according to Directive 93/42/EEC in Germany accreditation by ZLG.

C OEM does not operate as manufacturer in the meaning of the Directives and is not certified according to EN ISO 13485 : 2003.

3 Description of areas of responsibility The PLM must fulfil the requirements of Directive 93/42/EEC. A part of the tasks may be transferred to the OEM, whereas the total responsibility remains with the PLM.

Invariably the PLM must explain to the Notified Body in the context of the conformity assessment which activities/tasks he himself performs in the devices design and manufacturing process and which are performed by the OEM (e.g. "List of Responsibilities").

This can be done, for example, by a listing of the quality management aspects based on EN ISO 13485 : 2003. EN ISO 13485 : 2003 thereby also includes the relevant aspects of the Medical Devices Directives as well as additional national requirements.

Within a conformity assessment procedure according to Annex II (3) of Directive 93/42/EEC the PLM may not transfer the following aspects of his quality management system to the OEM2. These aspects have to be audited by the Notified Body. The respective requirements apply as well within a procedure according to Annex V of Directive 93/42/EEC.

1 The inclusion of the harmonised standard EN 46003 : 1999 into EN ISO 13485 : 2003 is currently being prepared. 2 The list of the aspects of the quality management system is based on the structure of the EN ISO 13485 : 2003.

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Aspects of the quality management system Provision by PLM mandatory Quality management system General requirements X Documentation requirements X (including regulations for preparation, approval and

maintenance as well as location and availability of technical documentation, including list of Essential Requirements and determination of responsibilities for particular aspects)

management of OEM certificates (timely request for succeeding certificates and check of content of certificates)

Management responsibility X Management commitment Customer focus Quality policy Planning Responsibility, authority and communication Management review Resource management X (at least regulations concerning the activities at the

PLM and description of the interface with the OEM)

Provision of resources Human resources Infrastructure Work environment Product realization

Planning of product realization X (at least planning of PLM concerning product realization at OEM)

including execution and documentation of risk analysis/risk management

Customer-related processes X Design and development X

for procedures according to Annex II (3) of Directive 93/42/EEC at least a system for the design and development of OEM products (with at least determination of specifications, verification and validation of such products, including execution and documentation of clinical evaluation)

system for preparation and approval of instruction for use and labelling

Purchasing X Production and service provision X (at least regulations for identification and

traceability)

Control of monitoring and measuring devices X (at least regulations concerning the activities at the PLM)

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Measurement, analysis and improvement General X Monitoring and measurement X (at least regulations concerning vigilance

respectively feedback and internal audit)

Control of nonconforming products X Analysis of data X Improvement X (at least corrective and preventive actions)

4 Minimum documentation to be submitted Depending on the certification of the OEM (cases A, B, C), different documents must be submitted as minimum documentation or different aspects must be regulated in the agreement between OEM and PLM in the conformity assessment procedure for the PLM (see also 5).

4.1 Minimum documentation in case A The OEM also operates as manufacturer in the meaning of the Medical Devices Directives for the device concerned and is certified accordingly under the relevant Medical Devices Directive by the Notified Body.

A 1 The quality assurance system of the OEM has been certified according to Annex II, V or VI, but a product certification according to Annex II (4) or III is not required In this case, the Notified Body has to be provided with the following documents

Application of the PLM for the conduct of a conformity assessment procedure Regulation of re ponsibilities, e.g. in the form of a "List of Responsibilities" Documented quality management system of the PLM Declaration of conformity of the PLM Valid certificate(s) according to the relevant Medical Devices Directive of the OEM Declaration of conformity of the OEM that the OEM device and Private Label device

are identical/are identical except for ....

Labelling/instruction for use of the Private Label device (including intended use and limitation of use) to compare with the requirements of the relevant Directive and with the information from the OEM

Labelling/instruction for use of the OEM device already approved (including intended use and limitation of use)

Regulation between OEM and PLM (see 5) Technical documentation part A [1]. A transfer of the conformity assessment procedure according to Annex II for class IIb products to a procedure according to Annex III combined with Annex V or VI is only possible if the PLM additionally conducts a procedure according to Annex III for these products.

A transfer of the conformity assessment procedure according to Annex II for class IIb products to a procedure according to Annex III combined with Annex V or VI is only

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possible if the PLM additionally conducts a procedure according to Annex III for these products.

If the OEM holds a certificate according to Annex V for the product in question (for products of class IIa in combination with Annex VII, for products of class IIb and III in combination with Annex III), the product may be included in the scope of an already existing certificate of the PLM according to Annex II. In doing so, it must be assured that the PLM has established a system for the design and development of OEM products and has applied this system to the product in question. The system of the PLM for the design and development of OEM products must at least comprise the determination of the specifications, the verification and the validation of such products.

A 2 The quality assurance system of the OEM has been certified according to Annex II (3) and his product according to Annex II (4) In addition to the documents mentioned under A 1, the PLM has to provide or to be provided

the report on the EC type-examination from the Notified Body of the OEM which has to include the examination of the technical documentation

a comprehensive documentation out of which the Notified Body can see the changes of the PLM product compared with the OEM product

on demand, the complete technical documentation of the OEM. Since these changes are normally restricted to labelling/instruction for use and/or appearance, labelling/instruction for use and accompanying documentation have to be checked as a matter of principle. Before issuing an EC design-examination certificate the Notified Body of the PLM has to check at least identity and plausibility. Since the Notified Body is fully responsible for the issued certificates, it has to assure that all documents relevant for assessment are available and that the decision to issue a certificate is traceable on the basis of the available documents. This may require inspection of the full technical documentation of the OEM.

To prove the validity of the EC type-examination for the OEM product the document 3.9 B 15 [2] has to be applied accordingly.

In any case, the EC design-examination and the assessment of the quality assurance system of the PLM have to be conducted by the same Notified Body (modules may not be split).

A transfer of conformity assessment procedures according to Annex II (3) and II (4) for class III products to procedures according to Annex III and V is only possible if the PLM additionally conducts an EC type-examination (Annex III) for these products.

A 3 The quality assurance system of the OEM has been certified according to Annex V or VI and his product according to Annex III In addition to the documents mentioned under A 1, the PLM has to provide or to be provided

the report on the EC type-examination from the Notified Body of the OEM which has to include the examination of the technical documentation

a comprehensive documentation out of which the Notified Body can see the changes of the PLM product compared with the OEM product

on demand, the complete technical documentation of the OEM.

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Since these changes are normally restricted to labelling/instruction for use and/or appearance, labelling/instruction for use and accompanying documentation have to be checked as a matter of principle. Before issuing an EC type-examination certificate the Notified Body of the PLM has to check at least identity and plausibility. Since the Notified Body is fully responsible for the issued certificates, it has to assure that all documents relevant for assessment are available and that the decision to issue a certificate is traceable on the basis of the available documents. This may require inspection of the full technical documentation of the OEM.

To prove the validity of the EC type-examination for the OEM product the document 3.9 B 15 [2] has to be applied accordingly.

Alternatively, the Notified Body of the OEM may issue the EC type-examination certificate for the PLM. Again, a check of at least identity and plausibility is necessary.

The Notified Body of a PLM may derive an EC design-examination certificate for a class III product from the EC type-examination certificate of the OEM if the quality assurance system of the PLM has been certified according to Annex II (3) for the respective group of devices. Again, the Notified Body has to check labelling/instruction for use and accompanying documentation as well as identity and plausibility.

A 4 The quality assurance system of the OEM has not been certified, i.e. conformity assessment procedure according to Annex III combined with IV or VII combined with IV Regarding EC type-examination see A 3.

The EC verification according to Annex IV has to be conducted by the manufacturer in the meaning of the Medical Devices Directives, i.e. the PLM, as a matter of principle. An OEM situation as described in this document does not exist.

This means, the Notified Body always must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Directive. With this, the Notified Body checks according to the regulations laid down in Annex IV whether the products conform to the type described in the EC type-examination certificate respectively the technical documentation.

4.2 Minimum documentation in case B The OEM does not operate as manufacturer in the meaning of the Medical Devices Directives, but is certified according to EN ISO 13485 : 2003.

Application of the PLM for the conduct of a conformity assessment procedure Regulation of the responsibilities, e.g. in the form of a "List of Responsibilities" Documented quality management system of the PLM Declaration of conformity of the PLM Valid certificate of the OEM according to EN ISO 13485 : 2003. This certification has to be

granted by a body authorised for this product/group of products by an authority competent for the designation of Notified Bodies according to Directive 93/42/EEC in Germany accreditation by ZLG.

Labelling/instruction for use of the Private Label device (including intended use and limitation of use)

Regulation between OEM and PLM (see 5)

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Technical documentation part A [1]. In addition, the OEM must be able to present an audit report for EN ISO 13485 : 2003, which contains information showing that appropriate evidence/information is available for all activities/devices delegated to the OEM in accordance with the list of responsibilities.

If these aspects are not included in an audit report, the evidence of the effectiveness of the OEM's quality management system with specific reference to the device concerned can also be provided in the form of supplementary comments by the certification body.

If the aforementioned evidence is not available, the procedure must be that described for case C.

4.3 Minimum documentation in case C The OEM does not operate as manufacturer in the meaning of the Medical Devices Directives and is not certified according to EN ISO 13485 : 2003.

In such a case the Notified Body must conduct a subcontractor audit because the conduct of a conformity assessment procedure is not only possible on the basis of the documentation submitted (please compare also introduction on page 1).

The PLM must be able to submit at least the following documents:

Application of the PLM for the conduct of a conformity assessment procedure Regulation of the responsibilities, e.g. in the form of a "List of Responsibilities" Documented quality management system of the PLM Declaration of conformity of the PLM Labelling/instruction for use of the PLM device (including intended use and limitation of use) Regulation between OEM and PLM (see 5) Technical documentation part A [1].

5 Contents of the agreement The PLM must provide evidence of detailed agreements with the OEM. In these agreements precise and mandatory provisions must be made concerning all requirements of the relevant Medical Devices Directive and of relevant national law, which the PLM cannot satisfy alone.

The items below will be checked and assessed by the Notified Body:

Scope of the agreement (devices/device groups concerned) Period of agreement's validity Detailed specifications for the respective devices Regulations governing who is responsible for which documentation (technical

documentation, DHR (Device History Record) etc.) incl. retention periods

Traceability of raw material/components to PLM Influence on device design by the PLM Regulations governing the procedure by which changes to the device and in the

manufacturing process are initiated, released, implemented and documented

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Right for the Notified Body and the Competent Authority of the PLM to examine the technical documentation

Regulations governing collaboration in the case of incidents/mandatory notification/recall Regulations governing access of Notified Bodies and Competent Authorities to the OEM' s

premises and those of his suppliers/subcontractors

Obligation to provide information where there are changes to the status of the certificates of the OEM and/or PLM

Dealing with customer complaints Where relevant, responsibility matrix (see above) The regulations of this document also apply to the scope of Directive 98/79/EC.

Reference 93/42/EWG Article 11 and Annexes II-VII

MEDDEV 2.5/3 rev. 2 Subcontracting Quality Systems related

[1] NB-Med/2.5.1/Rec. 5 Technical Documentation

[2] 3.9 B 15 EG-Auslegungsprfung, EG-Baumusterprfung Verlngerung der Geltungsdauer von Bescheinigungen3

Keywords manufacturer, conformity assessment, OEM, Private Label Manufacturer, supplier

Date of issue January 2007; replaces document 3.9 A 5; corrected June 2007

3 only available in German