E-ssentialsTÜV SÜD I Vol. 1 March 2013

Medical Devices | Technical industry e-news updates essential to your operations

Contents

In vitro diagnostics New European regulation is taking on form

Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDD) provides the current EU regulatory framework for In Vitro Diagnostic Medical Devices (IVDs). It establishes minimum requirements that are binding on all EU Member States and must be included in the respective national laws to ensure free trade of all In Vitro Diagnostic Medical Devices under its scope while supporting the highest level of protection of human health and safety. Following a public consultation in summer 2010, in which TÜV SÜD played an active role, and publication of its results in February 2011, a proposal for a harmonized European ”Regulation on In Vitro Diagnostic Medical Devices“ was drawn up by the commission and presented on September 26, 2012. The new regulation taken into consideration will introduce significant changes.

The old directive (IVDD) will be replaced by an EU regulation which will come into effect directly in all EU Member States without requiring transposition into national law. The new regulation will empower the Commission to take action. In the future, the Commission will be able to align requirements at short notice and change, say, the classification of individual devices. A central expert committee will be responsible for ensuring the harmonized interpretation of requirements. The future regulation also provides for closer monitoring of the Notified Bodies by the national authorities in cooperation with the EU. Existing designations will expire when the regulation enters into force. Designation under the new regulation requires re-assessment.

In vitro diagnostics 01

Determination of Shelf Life 03

Medical technology in Brazil 04

BSE symposium 05

FDA warns against toxins 06

EU – Australia 07

Preview of the next edition 09

Dear Readers,

April 7 is World Health Day. With this day of action, the World Health Organization annually highlights a theme for world-wide public attention which has strategic importance for the development of national health care systems. In the area of preventive health care, the breach between the developing and industrialized countries is, unfortunately, very large and the challenges faced by health care industry officials are completely different. Those of us in the Medical Device Industry are also affected. Europe has one of the most efficient approval systems for Medical Devices. The standards are harmonized and we work hard on ways to assure that our patients are well protected from fraudulent risks. Our experts cooperate scientifically and in standards committees with colleagues all over the world.

At the same time, there are some countries outside Europe which have extremely complicated approval procedures which delay patient access to ”state of the art“ medical technology through lack of harmonization or protectionist regulations.

As the world‘s largest Notified Body, our main concerns are the safety and effectivity of Medical Devices. We are committed to the goal of having people in many parts of the world obtain immediate access to the safest and most advanced Medical Devices in order to provide them with the best medical treatment in the world. It‘s always worthwhile to keep this in mind. Not only on World Health Day.

Best regards,Dr. Peter HavelSenior Vice President, Medical & Health Services Global

Editorial

Clear rules for manufacturers of Medical DevicesIn the future, the position of Notified Bodies vis-à-vis manufacturers will be strengthened, including the right to carry out unannounced factory inspections and physical or laboratory tests on samples. Compared to the IVDD, the new EU regulation establishes clearer requirements with respect to batch testing by the Notified Bodies. The conformity assessment procedure ”EC verification“ is no longer included.

The classification system for in vitro diagnostics has been changed significantly and is now based on classification rules instead of positive lists. In the future, IVDs will be divided into four classes of risk: A (lowest risk), B, C and D (highest risk). Even for class A devices, verification of the measuring function, sterilization process or design of near-patient testing by a Notified Body is mandatory as far as applicable. This basically means that many devices are now in a higher risk class and will be subject to assessment or more in-depth assessment by a Notified Body in the future. In the case of new applications for conformity assessment of high-risk devices, the proposal introduces an obligation for Notified Bodies to notify an expert committee. The expert committee will have the power to request the Notified Body to submit a preliminary assessment.

Furthermore companion diagnostics will be included into the regulation and special requirements will be defined for near-patient (point of care) testing. Compared to the current regulation, the scope of applications will be extended on those produced and used within one health institution, if they are classified into the highest risk class (class D).

Improved transparency in every respectEvery device will be given an unique device identification (UDI). Serious incidents regarding a device and the corrective actions taken to address them will be collated in a central EU-wide electronic system in the future. Manufacturers will have to appoint a qualified person responsible for regulatory compliance and fulfill stricter requirements in the field of post market surveillance.

Obligations imposed on importers and distributors too have clearly increased. The same applies to clinical performance studies, which will be subject to stricter regulations. The Commission will further designate reference laboratories to define the state of the art and carry out tests within the scope of the assessment procedure.

A contemporary and stable regulatory frameworkThe proposal for a regulation on In Vitro Diagnostic Medical Devices was published alongside a proposal for the revision of the Directives on Medical Devices and Active Implantable Medical Devices. By harmonizing the regulatory framework, the Commission aims at maintaining and improving the existing level of protection of human health and safety in the EU Member States. Some of the requirements of the IVDD lacked precision and leaded to some divergences in their interpretation and application. The classification system used so far proved too rigid to keep up with scientific and technological progress. Over the years changes and new risks that had not been addressed in the IVDD have evolved, including genetic tests and companion diagnostics. The revision also intends to overcome flaws in the old regulation, thus further improving patient safety. The objective is to create a robust, transparent, sustainable and, above all, ”fit-for-purpose“ regulatory framework.

New regulation expected to start in 2014Within the scope of the EU legislative procedure, the proposal will now be submitted to the European Parliament for first reading. Passing of the new regulation following discussion and implementation of all changes resulting therefrom is expected in 2014. The regulation is to be applicable after a five-year transition period. Any certificates based on the IVDD issued by Notified Bodies before the regulation has entered into force will become invalid two years after the regulation‘s entry into force at the latest. Given this, manufacturers should keep their ears to the ground today. For them the costs and efforts involved in achieving regulatory compliance will increase significantly. Given this, additional resources must be established in a timely manner. Similarly, manufacturers must closely examine their QM systems and their processes, particularly those used to generate and document clinical data, and must review their available documentation for possible omissions. TÜV SÜD advises all manufacturers to strive early for an assessment carried out in accordance with the new regulation. In order to offer the required services at an early stage, TÜV SÜD is preparing intensively to meet the challenges of the new regulation and, as Notified Body, support manufacturers in taking all the necessary actions. n

contactDr. Dieter Schönwald

+49 89 5008-4241

@ dieter.schoenwald@tuev-sued.de

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Within the scope of Medical Device Risk Assessment manufacturers must, inter alia, define the shelf life of the device. However, there are some divergences in the interpretation of the applicable essential requirements by manufacturers and Notified Bodies. With respect to the relevance of the information contained and the formal aspects, some manufacturer documentation does not meet the criteria that TÜV SÜD considers essential for validation. Based on an expert opinion by the Central Authority of the German Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG), TÜV SÜD gives helpful tips on what manufacturers should look out for, particularly in the validation of shelf life.

Depending on the device, technological, chemical, physical, microbiological and/or toxicological aspects of the device and its packaging may have to be considered to determine shelf life. Directive 93/42/EEC, Annex 1, defines the essential requirements in this context, while the normative requirements made on the control of documents and records are set forth in EN ISO 13485.

Realistic scenarios for significant test resultsSome of the requirements prone to frequent divergences in interpretation concern the selection of the production batches to be tested. In TÜV SÜD‘s opinion, testing should be carried out on a minimum of three batches to eliminate variability caused by the production process and raw materials. In accordance with GMP requirements, the test intervals must be risk-based and distributed across the entire shelf-life period. The test parameters selected must significantly reflect the relevant characteristics of the Medical Device up to the end of the shelf life. If the manufacturer submits (historical) data, these data must show that they are valid and applicable to the current validation.

The same applies to the storage and climatic conditions in which testing is performed. TÜV SÜD critically reviews whether these conditions comply with the actual market conditions and the climate zones in the target markets. Parties wishing, for example, to place a catheter-lock solution on the market which will be stored in air-conditioned hospitals but also in emergency vehicles without air-conditioning need a regulation aligned to their specific situation.

Special attention on artificial ageingManufacturers that use artificial ageing must describe the extent to which the selected parameters permit realistic statements to be made about the product, its packaging and the period in question. After all, common calculation procedures in accordance with Arrhenius‘s law do not per se take into account the combination of individual materials in a device and its packaging. Artificial ageing at high temperatures of a dental instrument made of steel in blister packing, for example, supplies information about the ageing of the packing material rather than about the ageing of the instrument itself. The Arrhenius equation, furthermore, is not suitable for use in temperature ranges in which a Medical Device undergoes changes caused by thermal impact, i.e. through deformation or phase transformation. As a general rule the following applies: The data obtained with accelerated ageing must be verified by comparing them against the data obtained with normally aged products later on.

First the criteria – then the testAs a Notified Body TÜV SÜD validates ”Shelf-life determination within the scope of certification in accordance with Annex II (3), Annex II (4) and Annex III“. To ensure rapid processing, the experts advise discussing and agreeing the criteria for shelf-life determination at an early stage to avoid further demands and tests later on. In this context, TÜV SÜD supports manufacturers, offering review of the solutions and validation plans even before the start of the shelf-life tests.

Determination of Shelf Life What manufacturers should look out for

Definition:”Shelf life“ refers to the durability under specified storage and transport conditions defined by the manufacturer until the immediate packaging is opened for the first time. n

contactDr. Peter Bernhardt

+49 89 5008-4595

@ peter.bernhardt@tuev-sued.de

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The growing healthcare market in Brazil is raising high expectations, also among German manufacturers of Medical Devices. However, the approval procedure there – in particular, that for Active Medical Devices – has its pitfalls. Before manufacturers can register their Medical Devices with the Brazilian health surveillance agency ANVISA (Agência Nacional de Vigilância Sanitária) they need INMETRO (Instituto Nacional de Metrologia, Normalização E Qualidade Industrial) certification. The approval procedure at a glance:

Phase 1: Representative and classificationForeign manufacturers need an in-country representative recognized by ANVISA to register their devices with the authority. Brazil‘s classification rules are very similar to those specified in Annex XI to the MDD. Careful attention is required right from step one, which may impact on the validity period of the registration and thus on market planning.

Phase 2: INMETRO certification for Active Medical DevicesAll Active and some Non-Active Medical Devices need INMETRO certification before they can be registered with ANVISA. Within the scope of this certification, test reports must be submitted. Generally, IEC test reports created for CE approval or other purposes are recognized, provided they were prepared by a testing laboratory accredited by an ILAC member. In some cases there are national deviations and manufacturers must prove in additional tests that their products comply with these national deviations. INMETRO certification further requires factory inspection at the manufacturer. Annual re-certification is necessary to maintain the certification status.

INMETRO certification also includes assessment of the manufacturer‘s quality management system, which must be in compliance with the BGMP (Brazilian Good Manufacturing Practice). Verification of BGMP compliance is effected within the scope of inspections that can only be carried out by ANVISA. These inspections are conducted every two years and generally take four to five days. ANVISA does not authorize any inspections carried out by third-party organizations such as TÜV SÜD.

Phase 3: Registration by ANVISATogether with the INMETRO certification and the ANVISA inspection certificate, manufacturers must submit complete technical documentation for registration. Generally, the technical documentation prepared for CE approval in Europe is sufficient. The associated test reports must not date back more than two years. From January 2014, the 3rd Edition of the IEC 60601-1 standard will apply exclusively. Usually, ANVISA does not accept clinical studies performed outside Brazil.

Stakeholders wishing to register their products on the Brazilian market must also furnish proof that their products are approved in their country or in other markets. For some Medical Devices, manufacturers must submit an economic information report containing information about device pricing in other countries, the number of patients using the device, the service life and other details.

The duration of the registration process in Brazil essentially depends on two phases. Up to one and a half years can pass between the filing of the application for a first inspection with ANVISA and its implementation by that body. Depending on the device‘s risk and the complexity category, the review at ANVISA may take between six and twelve months. Given this, a total period of more than two and a half years can pass before a new device can be placed on the market in Brazil. The validity of registration is restricted to five years.

Medical technology in Brazil Attractive market with complex approval procedure

contactGeorg Bauer

+49 89 5008-4143

@ georg.bauer@tuev-sued.de

Accreditation by ILAC membersThe testing laboratories of TÜV SÜD recently obtained DAkkS accreditation. As the DAkks is a member of ILAC, our clients‘ test reports are accepted for INMETRO certification. The same applies to the testing laboratories of Singapore-based TÜV SÜD PSB (SAC as ILAC member) and TÜV SÜD America (A2LA and NVLAP as ILAC members). n

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Not least thanks to effective EU legislation at various levels, BSE no longer dominates the headlines in the major daily newspapers. By publishing its Regulation (EU) No. 722/2012, the European Commission has now established a new regulatory framework for utilising tissues of animal origin in Medical Devices. The regulation will come into effect in 2013, replacing former TSE Directive 2003/32/EC. At a symposium carried out by TÜV SÜD in October 2012 in Munich, international experts explained the backgrounds. A résumé of the most important legal changes and their effect on the manufacturers of Medical Devices.

Around 40 stakeholders followed the TÜV SÜD invitation and attended the BSE symposium at BMW Welt in Munich. The audience was an international one: representatives from industry, institutes, authorities, and Notified Bodies had travelled from China, the USA, Ireland and, of course, Germany to take part in the symposium. Nine high-profile speakers delivered a comprehensive update on TSE risks and the new EU regulatory framework for utilising tissues of animal origin in Medical Devices. The symposium focused on the new Regulation (EU) 722/2012 and its impacts on risk management when using tissues of animal origin or their derivatives in the manufacturing of Medical Devices in accordance with the ISO 22442 standard.

Update I: Risks and directivesThe significance of a harmonized EU regulatory framework to combat BSE was underpinned by three outstanding contributions from the world of research. Priv. Doz. Dr. Johannes Blümel from the Paul Ehrlich Institute and Dr. Anne Balkema-Buschmann from the Friedrich Löffler Institute informed the attendees about known patterns and variants of the disease and the resulting risks. Prof. David Asher, Head of the TSE laboratory at the FDA (Food and Drug Administration), outlined new findings from the USA on the deactivation and decontamination of BSE pathogens. Prof. Walter Schwerdtfeger presented the new EU legislation from the perspective of the German Federal Institute for Drugs and Medical Devices. The manufacturers‘ perspective, too, was given enough consideration at the symposium. In two technical talks and comprehensive rounds of discussion, the attendees spoke at length about the consequences involved for the Medical Devices industry.

Update II: Risk management at the manufacturerThe new Regulation (EU) No. 722/2012 was published on August 9, 2012. After entering into force on August 28, 2012, application of the regulation will become mandatory in all EU Member States on August 29, 2013. The regulation applies to devices that use tissues of animal origin (e.g. bovine heart valves or bovine bones as bone filler material) or derivatives from BSE-relevant animal tissues (e.g. collagen and gelatin). In the future, the regulation will explicitly also cover active implantable and custom-made Medical Devices (e.g. mandible transplants that are exactly fitted and designed for individual patients) and Medical Devices used in clinical investigations. For these devices, the new regulation defines requirements related to risk management, sourcing of materials and safety regarding the transmission of infectious agents.

The former GBR (”geographical BSE risk“) system for risk assessment is replaced by just three risk categories related to the country of sourcing.

In addition to the above, manufacturers will have to take a number of further changes into account and justify the use of tissues of animal origin to the Notified Body, taking into account the related risks. Manufacturers must collect, evaluate and submit to the Notified Body all information on significant changes with regard to the TSE risk of the Medical Device. The Notified Body will then decide whether the changes result in an increase of the overall TSE risk and whether the already approved device may have to be re-assessed.

Update III: EU certificates and certification marksThe regulation includes a significant change for manufacturers using starting materials that have already been certified by the EDQM (European Directorate for the Quality of Medicines & Healthcare). So far, Medical Devices made of these materials have been exempted from consultation with all EU member states. However, in accordance with the new regulation a consultation procedure, albeit shortened to four weeks, is now also required for these devices.

Manufacturers of Active Implantable Medical Devices that include BSE-relevant material of animal original also must engage in consultation with the EU authorities. Manufacturers of Active Medical Devices covered by an EC type examination certificate must apply to their Notified Body for a complementary certificate attesting compliance with the new regulation. Compliance with the new regulation is also imperative for the (continued) use of the CE marking.

Alongside the publication of the new TSE regulation, the EU introduced stricter requirements for Notified Bodies throughout the EU, and stepped up monitoring of these offices. For instance, all EU Member States must verify and inform the EU Commission by February 28, 2013 that their Notified Bodies have the necessary expertise and up-to-date knowledge.

Interested parties who missed the symposium in Munich can also contact TÜV SÜD to obtain timely and direct information on the new requirements and initiate any tests that may be necessary before the changes come into effect.

A PDF-file of the COMMISSION REGULATION (EU) No. 722/2012 of August 8, 2012 concerning particular requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to Active Implantable Medical Devices and Medical Devices manufactured utilising tissues of animal origin is available here. n

BSE symposium Everything about the new Regulation (EU) No. 722/2012

contactProf. Dr. Sabine Kloth

+49 89 5008-4499

@ sabine.kloth@tuev-sued.de

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FDA warns against toxins No Jatropha derivatives in Medical Devices!

The FDA (US Food and Drug Administration) warns against the use of oils, glycerin or protein derived from the Jatropha plant, which may have toxic effects. Derivatives from the Jatropha plant can be used in the production of food, cosmetics and Medical Devices. The FDA requests all manufacturers to monitor and audit their supply chains and naturally derived ingredients.

Boom of the Jatropha plantJatropha is a genus of flowering plants in the spurge family (Euphorbiaceae). The undemanding shrub flourishes excellently in tropical and sub-tropical climates and can be easily and cost-effectively cultivated at commercial level. Jatropha seeds contain over 30% oil. With a cetane number of around 60, Jatropha oil is one of the world‘s most suitable vegetable oils for use in technical applications. At present, the global cultivation area is under one million hectares. However, according to new studies, global cultivation potential amounts to around 30 million hectares. Around 80% of the areas currently used for Jatropha cultivation are located in Asian countries, above all India, China and Indonesia. However, commercial Jatropha cultivation is also booming in Latin America and Africa. The oil is primarily used in biodiesel production. However, the by-products of biodiesel production, namely oil, glycerin and proteins, can also be used in the production of food, cosmetics and Medical Devices.

Toxins suspected in Jatropha derivativesIn its notification of July 6, 2012, the FDA points out that the Jatropha plant may contain toxic compounds including phorbol esters, which may exhibit potential toxicity, acute and chronic, to exposed humans and animals. Given this, the FDA warns against consciously or unconsciously using derivatives of the Jatropha plant in the production of food, cosmetics and Medical Devices. An especially problematic aspect according to the FDA is that conventional impurity test methods may not detect the presence of these toxins. Given this, the FDA advises industry to monitor their supply chains and the composition of naturally derived ingredients that may contain Jatropha derivatives. The FDA recommends that manufacturersn are familiar with, monitor, and audit supply chains of naturally-derived ingredients,n conduct comprehensive risk assessment for naturally derived ingredients, even if the composition of ingredients has been verified and so far did not pose a risk, andn confirm the composition of naturally derived ingredients and conduct appropriate testing of these ingredients.

Call for cooperationThe FDA is monitoring this situation to assess possible impacts on FDA-regulated products and will provide updates as additional information becomes available. Furthermore, the FDA is working on developing test methods for Jatropha-based ingredients and asks all suppliers and manufacturers of FDA-regulated products to share their information about Jatropha derivatives or to contact the FDA if Jatropha-based toxins are suspected. The FDA particularly asks for notification if effective testing methodologies are developed.

Further information can be found here:FDA Notification to Industry, July 6, 2012Wikipedia entry on the Jatropha plant n

contactDr. Bassil Akra

+49 89 5008-4429

@ bassil.akra@tuev-sued.de

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EU – Australia Amended Mutual Recognition Agreement

Since 1999, the EU and Australia have mutually recognized conformity assessments, certificates and markings. The Mutual Recognition Agreement (MRA) allows performing conformity assessments for products manufactured in Europe according to Australian regulations and, subsequently, marketing the products within Australia. With effect from January 1, 2013 this agreement has been amended and includes significant changes in the provisions concerning Medical Devices. This means that manufacturers must consider major changes regarding registrations for the Australian market.

On January 1, 1999 the “Agreement on Mutual Recognition in Relation to Conformity Assessment, Certificates and Markings between the European Community and Australia” came into effect. One of its sectoral Annexes contains the provisions concerning Medical Devices.

TÜV SÜD Product Service GmbH is designated by its competent authority as a Conformity Assessment Body under the scope of the aforementioned sectoral Annex and is therefore authorized to assess the conformity of products manufactured in Europe with Australian Medical Device Regulations. A certificate that confirms compliance with Australian Medical Device regulations is issued following a positive result of the assessment. This certificate is the manufacturer´s basis for the registration of the device in the Australian Register of Therapeutic Goods (ARTG) without any further need for a complete registration process including review of the technical documentation and audits.

This agreement has been amended and entered into force on January 1, 2013. Herein, the sectoral Annex for Medical Devices has been completely replaced. This may cause considerable impact on manufacturers’ registration planning for the Australian market.

Preliminary transition arrangementsPreliminary transition arrangements have been agreed to by the European Union and Australia as follows:n Conformity assessment certificates issued under the current MRA for

Medical Devices – that will become excluded from the scope of the MRA by the Amending Agreement – will continue to be valid after the Amending Agreement comes into force until the certificate expiry date or 5 years from the date that the Amending Agreement comes into effect, whichever is earlier.

n Conformity Assessment Bodies that are designated under the current MRA to issue certificates for Medical Devices – that will become excluded from the scope of the MRA by the Amending Agreement – will be considered to be designated under the Amending Agreement for the purpose of maintaining such certificates until the certificate expiry date or five years from the date that the Amending Agreement comes into effect, whichever is earlier.

n Any new conformity assessment certificates issued under the MRA once the Amending Agreement comes into effect must be issued according to the provisions of the new Amended Agreement.

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The main changesThe Amendment contains the following significant changes:n A ”rule of origin“ clause (which stipulates that only those products

manufactured in the European Union or Australia are covered by the MRA) has been removed from the overarching MRA and replaced with a more specific clause in the Medical Devices Sectoral Annex. Activities such as repairing, reconditioning, refurbishment, labelling, packaging, quality control inspections alone, or sterilization alone, will be specifically excluded from the definition of ”manufacture“.

n Extension of scope – radioactive Medical Devices of lower risk classes will be included in the MRA.

n Temporary exclusion – the Amending Agreement expands the range of high risk Medical Devices that will no longer be able to be assessed under the MRA, until confidence building activities have been undertaken by Australia and the European Union. These are: - active implantable devices as defined in the legislation referred to in Section I;

- devices that are classified as class III devices under the legislation referred to in Section I;

- Medical Devices that are implantable intra-ocular lenses; - Medical Devices that are intra-ocular visco-elastic fluids, and - Medical Devices that are a barrier indicated for contraception or prevention

of the sexual transmission of disease.n Following combination products are completely excluded from the scope:

- Medical Devices that contain or are manufactured using cells, tissues or tissue derivatives of animal origin that have been rendered non-viable, where the safety with regard to viruses or other transferable agents requires validated methods for elimination or viral inactivation in the course of the manufacturing process;

- Medical Devices that contain tissues, cells or substances of microbial, bacterial or recombinant origin and are intended for use in or on the human body;

- Medical Devices incorporating tissues or tissue derivatives of human origin; - Medical Devices incorporating stable derivatives of human blood or

human plasma that are liable to act on the human body in a way that is ancillary to the device;

- Medical Devices that incorporate, or intend to incorporate, as an integral part, a substance that, if used separately, might be considered to be a medicine that is intended to act on a patient in a way that is ancillary to the device, and

- Medical Devices that are intended by the manufacturer specifically to be used for chemical disinfection of other Medical Devices, except for sterilizers using dry heat, moist heat or ethylene oxide.

Further information can be found here:Information provided by European UnionInformation provided by Australian Therapeutic Goods Administration n

contactGeorg Bauer

+49 89 5008-4143

@ georg.bauer@tuev-sued.de

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DISCLAIMERAll reasonable measures have been taken to ensure the quality, reliability, and accuracy of the information in this newsletter. However, TÜV SÜD is not responsible for the third-party content contained in this newsletter. TÜV SÜD makes no warranties or representations, expressed or implied, as to the accuracy or completeness of information contained in this newsletter.This newsletter is intended to provide general information on a particular subject or subjects and is not an exhaustive treatment of such subject(s). Accordingly, the information in this newsletter is not intended to constitute consulting or professional advice or services. If you are seeking advice on any matters relating to information in this newsletter, you should – where appropriate – contact us directly with your specific query or seek advice from qualified professional people. The information contained in this newsletter may not be copied, quoted, or referred to in any other publication or materials without the prior written consent of TÜV SÜD. All rights reserved © 2013 TÜV SÜD.PHOTO CREDITSPage 1: luchschen; Page 2: Johny Keny; Page 3: Nomad_Soul; Page 4: epstock; Page 6: akkaradech; Seite 7: ruskpp; Page 9: Artens; all photos from shutterstock.com

Your Medical Device contacts worldwideGermanyTÜV SÜD Product Service GmbHRidlerstrasse 6580339 Munich+49 89 5008-4747

ItalyTÜV Italy S.r.l.Via Isonzo, 6140033 Casalecchio di Reno (BO)+39 051 298-7411

United KingdomTÜV SÜD Product Service Ltd.Octagon House, Concorde WaySegensworth NorthFareham – Hampshire PO15 5RL+44 1489 558217

USATÜV SÜD America Inc.10 Centennial DrivePeabody, MA 01960+1 978 5732500

Asia-PacificTÜV SÜD PSB Pte. Ltd. 1 Science Park DriveSingapore 118221+65 6778 7777

Or by e-mail to info@tuev-sued.de

Preview of the next edition: MDD revisions – what manufacturers need to know

On September 26, 2012, the European Commission published the proposals for the new regulations on Medical Devices and In Vitro Diagnostic Medical Devices (see also page 1 of this edition). These proposals have been debated in the committees of the EU Council and the EU Parliament since October. Passing of the new, harmonized legislation is expected in 2014. Manufacturers of Medical Devices must prepare themselves for significant changes in the conformity assessment procedure. After a transition period of three years for Medical Devices and Active Implantable Medical Devices and five years for In Vitro Diagnostic Medical Devices, the conformity declarations valid so far will become invalid. This means that all products falling under the scope of these directives must be re-assessed by 2017 or 2019 respectively. In the next edition of E-ssentials we will provide detailed information on the new MDD and what you should already take into account now.

Information pages on the new MDD and IVD of the EU Commission can be found here. n

contactReiner Krumme

+1 651 6380278

@ rkrumme@tuvam.de

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