medical devices e-ssential newsletter_sep_2012

E-ssentialsTÜV SÜD I Vol. 2 September 2012

Contents

Revision of Directive 2003/32/EC Symposium on TSE/BSE with representatives from authorities in autumn

High-profile speakers, topical themes, first-class location – the symposium on “European legislation for material of animal origin is changing – what manufacturers need to consider” aims to communicate the current status of BSE and TSE to manufacturers in the area of tissue engineering. In October, experts including Prof Walter Schwerdtfeger, Dr Robert Geertsma and Prof David Asher will talk at BMW Welt on the revision of directive 2003/32/EC (BSE Directive), its impact on the ISO 22442 standard and the views and interpretations of the authorities.

On October 23, 2012, TÜV SÜD will invite interested parties to BMW Welt in Munich to meet with representatives from German, European and US authorities, including the Food and Drug Administration (FDA) and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and other manufacturers and Notified Bodies, and inform themselves about the latest news and developments in this area.

The symposium “European legislation for material of animal origin is changing – what manufacturers need to consider” will be held in English. It starts at 8:45 am and ends at around 6:00 pm. The price per person is 390 euros plus value added tax (VAT). Included are refreshments, lunch and a guided tour of BMW Welt.

You can find detailed information about the event and the agenda at www.tuev-sued.de/bse-symposium.

Revision of Directive 2003/32/EC 01

Medical in-house expertise: Clinical Affairs (Part 2) 02

IEC 60601-1: 2005 3rd edition, Amendment 1 04

MEDDEV 2.12-1 rev. 7 05

International approvals: Russian Federation 06

International approvals: Australia 07

IEC 62366/IEC 60601-1-6 08

IEC 62653/ISO 9001 09

IEC 60601-1-9 10

Dear readers,

Although viewed as a tiresome obligation by many, certification can in fact be a voluntary measure that greatly benefits organizations. By presenting “Good Dialysis Practice”, we show you in this issue that voluntary certification can be worthwhile in more ways than one. As in previous issues, we also inform you about the most important changes in the “compulsory programme”, specifically the new requirements set forth in Amendment 1 to IEC 60601-1:2005 3rd edition. In addition, one of our experts reports on the most common weaknesses and nonconformities found in usability testing. We also take a look behind the scenes at TÜV SÜD and introduce you to Clinical Affairs, the only clinical in-house department at a Notified Body in Germany.

In this issue, we also launch a new series on the approval of medical devices in different countries. The first two countries are Australia and the Russian Federation. Here, we not only inform you about the certification process and the competent bodies, but supply you with valuable tips on how to save costs.

I hope you find our newsletter an interesting and informative read.

Best regards,

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

contactRalph Urbanek

+49 89 5008-4315

@ [email protected]

Editorial

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

Medical in-house expertise: Clinical AffairsWhat exactly are “clinical data” – or rather, what in detail are the requirements they have to meet? This question is repeatedly asked by medical devices manufacturers, and not without reason. The relevant regulatory acts and standards do not include any detailed requirements defining the type of data and numerical limits that might have to be complied with. For manufacturers, this could turn into a costly problem. Luckily, this problem can be avoided with the help of TÜV SÜD’s Clinical Affairs department.

The certification of all classes of medical devices in accordance with European Directive 2007/47/EC or the Medical Devices Law requires “clinical data”. In practice, however, many manufacturers go through the requirements only formally without clarifying possible difficulties of understanding in the run-up to the procedure. This frequently proves a costly omission because the “clinical data“ sourced often fail to meet the legal requirements. Manufacturers who fail to prove an positive clinical benefit/risk ratio will not obtain a certificate for their devices.

Experience and know-howIn view of the lack of detailed requirements, what is expected from Notified Bodies? There must be sufficient expertise regarding pathology, therapeutic alternatives, and background knowledge that enables them to evaluate the submitted “clinical data” critically, expertly and efficiently. To cater to this need, many years ago TÜV SÜD established Clinical Affairs, the only clinical in-house department at a Notified Body throughout Europe. Its employees, exclusively physicists from various medical areas with years of clinical practice and experience, deliver the necessary expertise. Additionally, there is in-depth expertise with preclinical testing and clinical studies.

However, Clinical Affairs scores in other areas too: in addition to the department’s long-standing expertise in the regulatory sector, clients benefit from its intensive interaction with various national and international authorities. The medical experts from Clinical Affairs also sit on regulatory and medical expert committees. Clients seeking even greater expertise and experience can rest assured: if necessary, the Clinical Affairs specialists can contact TÜV SÜD’s Scientific Advisory Board for advice and support at any time.

Thus prepared, the department can offer expert support and assistance to medical devices manufacturers throughout all stages of product design and development. We review your documents to ensure compliance with the Medical Devices Directive prior to certification. However, we also offer assistance before that stage, such as during design and development, evaluating your solutions for the sourcing of “clinical data” in specific cases or your plans for preclinical or clinical studies. In addition, our Clinical Affairs experts offer various training courses on “Clinical data for medical devices”. The comprehensive service portfolio of the Clinical Affairs department is rounded off by consultation procedures for drug/device combination products.

contactBassil Akra

+49 89 5008-4429

@ [email protected]

TÜV SÜD E-ssent ials

Vol. 2 September 2012Value-added partner TÜV SÜD – Part 2

TÜV SÜD E-ssent ials

Vol. 2 July 2012Value-added partner TÜV SÜD – Part 2

Your Clinical Affairs Team

Dr. med. Herbert LaiackerMedical Evaluation

Dr. Ing. Bassil AkraManager Clinical Affairs

Nicole Eun Joo HeimererMedical Evaluation

Ines HertesTeam Assistant

+49 89 5008-4421

The Amendment 1 to IEC 60601-1 3ed was published as IEC version in July 2012. This version from July 2012 (ISBN 978-2-83220-227-2) reflects solely the Amendment 1 changes. For daily work a much better readable version was published shortly later in August 2012 as consolidated version of IEC 60601-1:2005+A1:2012 (ISBN 978-2-8322-0331-6), where the changes of the Amendment 1 are incorporated in the main body of IEC 60601-1:2005 and are colored, so that the reader easily can distinguish between the requirements which remain unchanged and which have been changed due to the Amendment 1.The amendment includes 496 changes of the existing IEC 60601-1:2005 standard. Every standard revision is the result of further development of the generally accepted state of the art. Given this, medical devices manufacturers should start to deal with the changed requirements as soon as possible.

It is planned that the Amendment 1 (A1) will have an IEC stability date up to 2019, meaning that no Amendment 2 is planned before 2019. If deemed necessary from the point of safety, the additional requirements of the A1 may also be incorporated into the design of medical devices before the transition periods expire.

Medical devices have been tested in accordance with the IEC 60601-1:2005 3ed. standard for roughly five years. Expiry of the transition periods in Europe and Canada has caused a sharp rise in the number of tests of medical devices carried out in the testing laboratories of the Notified Bodies. In view of this development, the standard itself has been under critical review for around one year. Within this scope, it became evident that the standard had failed to keep up with technological progress: some of the requirements were no longer up-to-date, while others proved unfeasible in practice. To overcome at least some of these deficits, the 3rd edition of the standard was supplemented by Amendment 1:2012 which essentially reflects the state of the art.

Content of Amendment 1

The comprehensive changes and additions to the IEC 60601-1 3ed standard start with the normative references (Section 2), updating many of the reference standards, continue with changes in terminology and definitions (Section 3) and also modify general requirements such as risk management (4.2), essential performance (4.3) and equivalent safety (4.5). The numerous amendments and corrections are distributed across the entire standard and can also be found in expanded requirements, test methods, documentation requirements and the revised Annex A. The goal is to avoid potential hazards, including electrical shock hazards, mechanical hazards, radiation hazards and hazards caused by excessive temperature. In addition, Amendment 1 includes more detailed requirements for product design and development.

Deadlines and transition periodsExperts expect the corresponding A1-EN standard to be published in January 2013. This standard marks the beginning of a three-year transition period in Europe, during which manufacturers must verify thoroughly whether their medical devices are in compliance with the standard, and thus also with Amendment 1. After expiry of this transition period, which may vary depending on the Part 2 standards, all medical devices in Europe must fulfil the additional or modified requirements set forth in A1 in order to continue claiming presumption of conformity with the essential requirements of European Directive 93/42/EEC in the future. Given this, TÜV SÜD's experts recommend that manufacturers address the current requirements at an early stage. Harmonization of the standard will presumably be effected in April 2013.

FAQ ListAmendment 1 is to ensure that the required safety of medical devices will be met in practice, among other issues. The EN 60601-1 3ed raised many issues among manufacturers and Notified Bodies alike concerning both the safety of medical devices and its implementation in Europe. The working group of the Notified Body NB-MED and the European Committee for electrotechnical standardization CENELEC have addressed this issue and prepared a list of FAQs concerning the 3ed. The intention behind this FAQ document is to ensure a largely standardized approach by manufacturers, Notified Bodies, testing and inspection organizations and approval authorities. For an overview of the contents of the FAQ list log on to the last issue 1 of this newsletter of April 2012. n

IEC 60601-1: 2005 3rd edition, Amendment 1 Medical devices manufacturers should be inform

contactMartin Schneeberg

+49 89 5008-4476

@ [email protected]

TÜV SÜD E-ssent ialsVol. 2 September 2012

The guidelines on a medical devices vigilance system (MEDDEV 2.12/1) have been updated and published as revision 7. This update also supplies manufacturers with new Report Forms. An important factor in this context is that manufacturers take note of the amended/ requested information in the Report Forms. A short summary of the changes is provided below.

Annexes 3 and 4 to the guidelines now contain new Manufacturer‘s Incident Report and Manufacturer’s Field Safety Corrective Action Report forms.

The Annexes also include two new forms based on templates developed by the Global Harmonization Task Force (GHTF):• Annex 6 “Manufacturer‘s Periodic Summary Reporting” (PSR) and • Annex 7 “Manufacturer‘s Trend Reporting”.

Also new is the Field Safety Notice template included in Annex 5 which is used for field safety corrective actions.

In addition to the new forms, the text of the guidelines was amended in some places. For example:

• Section 5.1.3.4: one new detail was added to “Protection Against A Fault Functioned Correctly”.

• The example of incorrectly labelled in-vitro diagnostic devices in Section 5.1.3.6 was deleted.

• The list of examples of reportable incidents in Annex 1 was updated.

The new MEDDEV forms are available here.

MEDDEV 2.12-1 rev. 7 Guidelines on a medical devices vigilance system updated

contactHeiko Imhof

+49 89 5008-4615

@ [email protected]


To get their products approved for the Russian market, medical devices manufacturers need two things: a certificate of registration and a declaration of conformity. TÜV SÜD offers its clients both the certificate of registration and the declaration of conformity as a full service package. This article informs you about what is important for launching your products successfully on the Russian market.

In the Russian Federation, registration is effected by the “Federal Service on Surveillance in Healthcare and Social Development” (Roszdravnadzor). Since the EU and the Russian Federation have not signed a mutual agreement on conformity assessment, medical devices approved in Europe cannot simply be imported into the Russian Federation but must fulfill additional regulatory requirements. To make matters even more complex, the requirements are only available in Russian, and Roszdravnadzor also expects communication and correspondence to be conducted in Russian. Many medical devices manufacturers are inadequately prepared for these requirements – a costly omission.

Step 1: Registration Medical devices manufacturers that want to export their products to Russia must first designate a local representative. Successful registration, confirmed by a certificate with unlimited period of validity, marks the first milestone on the way to market approval. The certificate of registration is issued either to the manufacturer or its local representative, e.g. a distributor. Important in this context is that medical devices can only be imported by the holder of the certificate of registration. Successful registration requires the applicants to submit a host of documents. Some of these documents, for example the User‘s Manual or labelling, must be in Russian. Roszdravnadzor then thoroughly reviews this documentation.

For the medical devices listed below, Roszdravnadzor further sets up an expert commission that additionally reviews the technical documentation:

• Class I and IIa medical devices for which no comparable product approved on the Russian market was identified.

• All class IIb and III medical devices.

The classification of medical devices is largely identical to that in Annex IX of the European Medical Devices directive

Step 2: Declaration of conformityThe declaration of conformity has replaced the well-known GOST-R certificate for the majority of medical devices. However, the declaration of conformity still confirms that a medical device is in compliance with the requirements of the applicable GOST-R series of standards. The declaration of conformity is valid for a period of up to three years and can be issued exclusively to the local representative in the Russian Federation.

ApprovalAfter both a certificate of registration and a declaration of conformity have been issued, the respective medical device can be imported and placed on the Russian market.

Voluntary GOST-R certificationDepending on the medical device, numerous manufacturers apply for voluntary GOST-R-certification. The rationale behind their approach is that the declaration of conformity replaced the GOST-R-certificate for many medical devices as recently as 2011 and that the latter is still considered synonymous with premium quality in the Russian Federation. Given this, voluntary certification may indeed be a good marketing and sales argument.

For the manufacturers of medical devices, it is of the essence that the approval process goes smoothly and can be planned. TÜV SÜD is capable of handling this process from start to finish. Based on our profound knowledge of the approval requirements and our fluency in Russian, we can ensure efficient approval of medical devices on behalf of manufacturers.

International approvals: Russian Federation Taking a shorter route on the long way east

contactAlexander Schapovalov

+49 89 5008-4309

@ [email protected]


International approvals: Australia To Australia in five days with the MRA certificate

Australia is among the twelve richest countries in the world. However, with only a handful of its own high-tech manufacturers, the fifth continent depends on imports from other countries and is thus an attractive market for medical devices. Its regulatory authority is the TGA, which stands for Therapeutic Goods Administration. This article explains how medical devices made in Europe are approved for the Australian market. In addition, we inform you what to look out for to launch your product on the Australian market within only five days.

Synergy effects are the “secret” of time and cost savings. In other words, medical devices that have already been certified for the European market can go on to use exactly the same technical documentation that was required for certification there in order to gain market approval in Australia. This process is based on the Mutual Recognition Agreement (MRA) between Australia and the European Union governing conformity assessments, certificates and markings. TÜV SÜD is accredited as a Conformity Assessment Body (CAB) under this MRA (Sectoral Annex on Medical Devices), and thus authorized to carry out conformity assessment of medical devices in accordance with the Australian requirements. In Australia, responsibility for assessing Australian medical devices for their conformity with the European requirements rests with the government agency TGA (Therapeutic Goods Administration).

The road to market approvalThe prerequisite for market approval within the scope of the MRA is that the European manufacturer has a local representative, the “sponsor”. After TÜV SÜD, in its role as CAB, has assessed the medical devices as being in conformity with the Australian requirements, TÜV SÜD issues the certificate of conformity. The sponsor lodges the MRA certificate via the DEAL (Device Electronic Application Lodgement) online system, together with various

other documents (for example the Australian declaration of conformity, EC certificates). Within five working days, TGA then uploads the medical device to the ARTG (Australian Register of Therapeutic Goods) database, which can be accessed by the public. After upload to the ARTG, the product can be placed on the Australian market. Manufacturers who have their products registered under the MRA save the efforts involved in review of the technical documentation and, where applicable, an additional TGA audit. Registration processes not carried out under the MRA may take up to several months.

Exploiting synergiesTÜV SÜD‘s assessment of conformity with the Australian requirements is based on documents and certificates prepared within the scope of conformity assessment for the EU market in accordance with Directives 90/385/EEC and 93/42/EEC.

ExceptionsPlease take into account that the following medical devices are excluded from the MRA:

• Radioactive substances, in as far as these can be considered medical devices, and

• Medical devices that incorporate tissue of animal origin. However, medical devices

a) incorporating refined derivatives of animal derived waxes, heparin and gelatine that conform to pharmacopoeial standards and sintered hydroxyapatite or

b) incorporating tissues of animal origin, and where the device is intended to come into contact with intact skin only,

are included within the scope of this Sectoral Annex.

For further information on MRA certification log on to: Link.

contactGeorg Bauer

+49 89 5008-4143

@ [email protected]


The usability of medical devices ensures the safety of patients. The trend that medical devices are becoming increasingly complex while many users are only inadequately trained and instructed in their use causes an unfortunate imbalance. The EN 60601-1-6 and EN 62366 standards establish a framework, showing manufacturers how to avoid this imbalance. Within the scope of medical devices certification, TÜV SÜD‘s experts repeatedly see the same mistakes in manufacturers‘ usability testing. However, what do manufacturers have to look out for if they do not want to jeopardize the market approval of their devices?

The EN 60601-1-6 and the EN 62366 standards require rethinking on the part of medical devices manufacturers right from the design and development process. At this early stage in the process they must start to assess the usability of their medical devices on an ongoing basis, aligning it with user requirements if necessary. This is done within the framework of a documented usability engineering process in conformity with the standard. During this process, the product will undergo practice testing in various work processes and environments to identify possible sources of mistakes and errors. The objective of the test method applied is firstly to ensure user satisfaction and, more importantly, to reach a level of safety that prevents errors in use as far as possible. Manufacturers carry out usability testing both in the laboratory and in the context of real-life scenarios. If possible, usability testing covers various situations, e.g. alarm condition, atypical working environments and normal everyday use by users. As usability has not yet been officially certified for the device being tested, this practice test is done “on the side”, i.e. not in real-world use. Within the scope of the practice test, users and operators are interviewed on the handling of the medical device and the findings gained then incorporated in the design and development process. In addition to the interview, TÜV SÜD recommends that manufacturers observe on-site how users handle the equipment.

A particularly important aspect in this context is that manufacturers document all measures derived from interviews and observations and all individual steps for the usability test.

The questions count!In their audit, the experts at TÜV SÜD check whether the product meets all usability requirements. In this context, auditors repeatedly notice that many manufacturers repeat the same mistakes in practice tests and interviews. Many manufacturers fail to consider the actual purpose of usability validation before the start of the process. The issue is the safety of the medical device. Given this, the questions asked are of particular importance. Many manufacturers only base their questions on everyday processes such as the medical care of patients in hospitals and special events. However, this does not say anything about the general safety of a medical device. For a complete picture, manufacturers must also include atypical processes, such as emergencies involving children, in their interviews and observations. Manufacturers also tend to ask only high-level clients. However, these clients are not a representative group of users in accordance with the definition of the standards because the expectations concerning a medical device by, say, registered practitioners may differ from those of high-level clients.

TÜV SÜD‘s auditors act on these incorrect processes. Some processes might have to be supplemented or even repeated, costing manufacturers a lot of time and money. In a worst-case scenario, involving systematic violations, the certificate might have to be withdrawn. Given this, TÜV SÜD recommends that manufacturers focus usability testing on safety-critical aspects before even commencing the test, prepare appropriate questions and select a representative group for the practice test.

Another aspect worth noting is that the requirements also apply to medical devices that are already established on the market. Another solution must be found for these devices to ensure their continued compliance with the basic requirements of the Medical Devices Act in the future:

• Risk management should take care of potential usability risks.• An effective system comprising customer complaints and surveillance

must be established.• User feedback must be evaluated on an ongoing basis. The result of

this evaluation must then produce a sufficient level of safety.

IEC 62366/IEC 60601-1-6 Usability – still a challenge

contactDr. Andreas Purde

+49 89 5008-4203

@ [email protected]


Effective immediately, the recently published international standard IEC 62653 together with ISO 9001 form the new basis of TÜV SÜD‘s “Good Dialysis Practice” certificate, replacing the VDE 0753-4 2009-5 standard only published in Germany. This voluntary certification scheme for dialysis centers assesses quality management (QM) and preventive safety measures. Read here about the requirements that dialysis centers have to fulfill and how they can benefit from voluntary certification. TÜV SÜD has issued the “Good Dialysis Practice” certificate for the past eleven years. At present the TÜV SÜD “Good Dialysis Practice” certification mark is used by around 600 dialysis centers in 18 European countries, Turkey and South Africa with a total of 12,500 staff. However, what criteria do dialysis centers have to fulfill to obtain this quality label? To ensure that QM and safety go hand in hand, TÜV SÜD‘s experts verify compliance with two standards. The quality-system requirements set forth in the ISO 9001 “Quality management systems – requirements” standard define the framework of how the criteria for a functioning and effective safety culture – clear structures, standardized work processes, appropriate resources, effective communication structures – can be established at the level of management. Also important in this context is regular employee training, which should be tailored to the level of knowledge and sphere of responsibilities of the

individual concerned. By contrast, the IEC 62653 “Guideline for safe operation of Medical Devices used for haemodialysis treatments” focuses on prevention: the QM system must address known hazards and risks, including extracorporeal blood loss, well in advance of commencing treatment procedures. In this context, the QM system defines preventive and corrective actions, thus minimizing the risk faced by patients. Another important element is a functioning culture of error. In concrete terms this means that any medical error that occurs must be analysed. Starting from this, preventive actions must be identified which are incorporated into the QM system and continuously improve the existing work processes.

Benefits for patients and dialysis centersCertification in accordance with TÜV SÜD‘s “Good Dialysis Practice” standard is voluntary. However, why should dialysis centers voluntarily undergo certification? Firstly, the QM system helps them to improve in-house efficiency and transparency, and thus to avoid errors. Secondly, dialysis centers ensure compliance with all present and future legal requirements. Thirdly, certification provides medical centers with a certain level of assurance that they operate in compliance with the applicable laws. And, if an incident during analysis still results in a legal dispute with a patient, certification may have a mitigating effect on any penalty. Another important point is the public image of a dialysis

center: An institute certified by TÜV SÜD can demonstrate documented safety and quality standards, visualized to the public by the TÜV SÜD certification mark.

Germany‘s Medical Devices Operators Regulation states in Article 2 General Requirements: “(1) Medical devices may only be operated, applied and maintained in line with their intended use, the provisions of this regulation, the generally accepted state of the art and occupational safety and health and accident prevention regulations.” The “generally accepted state of the art” also includes the IEC 62653 standard now published. n

IEC 62653/ISO 9001 Good Dialysis Practice: documented quality and safety

contactThomas Ludewig

+49 89 5008-4146

@ [email protected]


The purpose of medical devices is to support the fight against diseases and save human life. However, their functions and technical components may themselves pose risks for the environment and human health. Given this, the international standard IEC 60601-1-9 is designed to reduce the adverse environmental impacts of medical electrical equipment. The focus during design and production is on functionality, usability and functional safety. However, the legal framework also demands the inclusion of environmental protection aspects. In this context, the requirements governing the environmental compatibility of medical devices concern all phases of their life cycle. However, there are four important reasons why environmental aspects should play a role right from the design and development stage of medical electrical equipment.

1. Market access Market access is regulated by legal environmental protection requirements. In Europe these requirements are set forth in the following directives, now transposed into national laws: ROHS, WEEE, REACH etc.The standard addresses the various EU directives in detail to identify possible requirements for product design. To stand a chance later on the European market,

equipment must be designed in accordance with the relevant standards. This particularly includes issues concerning the use and disposal of toxic substances. Of course, the national requirements in non-European countries can vary greatly. However, in most industrialized countries regulations can be assumed to be at least similar.

2. Conformity with standardsIn some countries, the legal requirements may demand evidence of conformity with certain environmental standards. While the law defines the general framework of environmental aspects, the standards provide specific information about the implementation related to certain products. In the case of medical electrical equipment this is the IEC 60601-1-9 standard, an international standard governing environmentally conscious design of medical electrical equipment. Familiarity with this standard helps to take all necessary environmental aspects into consideration in the design process.

3. Product/process improvement Consideration of environmental aspects improves not only products, but also the product-related design and production processes. By reducing certain materials in the device and the use of, say, energy or resources, savings may be realized for both manufacturers and users.

4. Active political involvement Being informed about the application of environmental aspects in the design and production of medical devices may also come in useful for political issues. Driven by environmental policy, the environmental aspects of products will become an increasing topic of discussion in the future. To gain an informed and unbiased picture of the developments concerning the requirements that must be met by medical electrical equipment, stakeholders must know the interrelations and impacts of environmental aspects.

TÜV SÜD Academy offers the training course “Requirements for the reduction of environmental impacts caused by medical-electrical equipment”.The seminar aims at providing in-depth information about the four above arguments supporting environmentally conscious design of medical electrical equipment. In addition to these fundamental issues, the course also gives tips on implementation in practice. Even though the various European directives on environmental protection require only a limited number of aspects from the IEC 60601-1-9 standard for the sale of products in Europe, manufacturers should inform themselves about all aspects. After all, compliance with both the directives and client requirements plays a major role in product success.

IEC 60601-1-9 Environmentally conscious design of medical electrical equipment

contactMichael Sippl

+49 89 5008-4140

@ [email protected]

seminar

expert

contactBirgit Klusmeier

+ 49 89 5791-3306

@ [email protected]


TÜV SÜD provides you with exclusive comprehensive information on a host of topics – free of charge!

Standards & EU Guidelines• Council Directive 93/42/EEC• Design Dossiers• Extension of EC Certificates• IEC 60601-1:2005: 3rd Edition• IVD Directive 98/79/EC• Revision of MDD 93/42/EEC• Transition from 2nd Edition to 3rd Edition of

IEC/EN 60601-1:2005• Transition to EC Directive 2007/47/EC• Usability of Medical Devices

International Affairs• Access Australia• Access Russian Federation• Access USA and Canada

• Chinese Approval for Medical Devices• FDA 510(k)• Globalization of Medical Device Approval• Japanese PAL• PAL – Change Application and Notification• PAL – Fundamental Info• PAL – Maintain Approvals/Certificates• PAL – MHLW Movement• PAL – Transitional Measures for Approved

Medical Devices

Clinical Affairs• Advanced Therapy Medicinal Products• Assessment of Medical Devices

Incorporating Material of Animal Origin• Biological Evaluation• Biological Safety• Clinical Data Requirements for EC

Certificate Extension• Clinical Data Requirements in Era of

2007/47/EC• Human Blood Derivatives• Material of Animal Origin • Medical Devices utilizing Material of

Animal Origin• Tools for Tissue Engineering

Further Services• EN 60601-2-5 Therapeutic Ultrasound

Devices• EN 60601-2-37 Diagnostic Ultrasound

Devices• Medical Device Software• Quality Management in Dialysis

Partially available also in German

Download our free information from www.tuev-sued.com/medinfo.

Med-InfoRegular Information Bulletins for the Medical Device Industry

Your medical device contacts worldwideGermanyTÜV SÜD Product Service GmbHRidlerstrasse 6580339 Munich+49 89 5008-4358

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. Ldt. 1 Science Park DriveSingapore 118221+65 6778 7777

or by e-mail to [email protected]

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 © 2012 TÜV SÜD.PHOTO CREDITSPage 4: withGod; Page 5: Africa Studio; Page 6: Lasse Kristensen; Page 7: Davor Pukljak ; Page 8: l i g h t p o e t; Page 9: beerkoff; Page 10: Nickola_Che; all photos from shutterstock.com


medical devices e-ssential newsletter_sep_2012

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