Medical Devices E-ssentials is a complimentary TÜV SÜD e-newsletter that delivers updates on the latest regulations and standards, critical to your operations. In the September 2012 issue, we focus on: •Revision of Directive 2003/32/EC •Medical in-house expertise: Clinical Affairs (Part 2) •IEC 60601-1: 2005 3rd edition, Amendment 1

1. TÜV SÜD I Vol. 2 September 2012
E-ssentials
Medical Devices | Technical industry e-news updates essential to your operations
Editorial
Revision of Directive
Dear readers,
Although viewed as a tiresome obligation by many, certification can
2003/32/EC
in fact be a voluntary measure that greatly benefits organizations.
By presenting “Good Dialysis Practice”, we show you in this issue
Symposium on TSE/BSE with
that voluntary certification can be worthwhile in more ways than
one. As in previous issues, we also inform you about the most
representatives from authorities in autumn
important changes in the “compulsory programme”, specifically
the new requirements set forth in Amendment 1 to IEC 60601-
High-profile speakers, topical themes, first-class location – the symposium on
1:2005 3rd edition. In addition, one of our experts reports
“European legislation for material of animal origin is changing – what manufacturers
on the most common weaknesses and nonconformities found
need to consider” aims to communicate the current status of BSE and TSE to
in usability testing. We also take a look behind the scenes at
manufacturers in the area of tissue engineering. In October, experts including
TÜV SÜD and introduce you to Clinical Affairs, the only clinical
Prof Walter Schwerdtfeger, Dr Robert Geertsma and Prof David Asher will talk at
in-house department at a Notified Body in Germany.
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.
In this issue, we also launch a new series on the approval of
medical devices in different countries. The first two countries are
On October 23, 2012, TÜV SÜD will invite interested parties to BMW Welt in Munich to
Australia and the Russian Federation. Here, we not only inform
meet with representatives from German, European and US authorities, including the Food
you about the certification process and the competent bodies, but
and Drug Administration (FDA) and the Federal Institute for Drugs and Medical Devices
supply you with valuable tips on how to save costs.
(Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and other manufacturers
and Notified Bodies, and inform themselves about the latest news and developments in
I hope you find our newsletter an interesting and informative read.
this area.
Best regards,
The symposium “European legislation for material of animal origin is changing – what
Dr. Peter Havel manufacturers need to consider” will be held in English. It starts at 8:45 am and ends at
Senior Vice President, Medical & Health Services Global 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.
Contents
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 contact
Ralph Urbanek
IEC 62653/ISO 9001 09
89 5008-4315
+49
IEC 60601-1-9 10 @
ralph.urbanek@tuev-sued.de

2. Vol. 2 September 2012
TÜV SÜD E-ssentials Value-added partner TÜV SÜD – Part 2
Page 2
Medical in-house expertise:
Clinical Affairs
What 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-how
In 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.
contact
Bassil Akra
89 5008-4429
+49
@ bassil.akra@tuev-sued.de

3. Vol. 2 July 2012
TÜV SÜD E-ssentials Value-added partner TÜV SÜD – Part 2
Page 3
Your Clinical Affairs Team
Dr. Ing. Bassil Akra Dr. med. Herbert Laiacker
Manager Clinical Affairs Medical Evaluation
Nicole Eun Joo Heimerer Ines Hertes
Medical Evaluation Team Assistant
+49 89 5008-4421

4. Vol. 2 September 2012
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Page 4
IEC 60601-1: 2005 3rd edition, Amendment 1
Medical devices manufacturers should be inform
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.
The Amendment 1 to IEC 60601-1 3ed was published as IEC version Deadlines and transition periods
in July 2012. This version from July 2012 (ISBN 978-2-83220-227-2) Experts expect the corresponding A1-EN standard to be published in January
reflects solely the Amendment 1 changes. For daily work a much 2013. This standard marks the beginning of a three-year transition period
better readable version was published shortly later in August in Europe, during which manufacturers must verify thoroughly whether
2012 as consolidated version of IEC 60601-1:2005+A1:2012 (ISBN their medical devices are in compliance with the standard, and thus also
978-2-8322-0331-6), where the changes of the Amendment 1 are with Amendment 1. After expiry of this transition period, which may vary
incorporated in the main body of IEC 60601-1:2005 and are colored, depending on the Part 2 standards, all medical devices in Europe must fulfil
so that the reader easily can distinguish between the requirements the additional or modified requirements set forth in A1 in order to continue
which remain unchanged and which have been changed due to the claiming presumption of conformity with the essential requirements of
Amendment 1.The amendment includes 496 changes of the existing European Directive 93/42/EEC in the future. Given this, TÜV SÜD's experts
IEC 60601-1:2005 standard. Every standard revision is the result of recommend that manufacturers address the current requirements at an early
further development of the generally accepted state of the art. Given stage. Harmonization of the standard will presumably be effected in April
this, medical devices manufacturers should start to deal with the 2013.
changed requirements as soon as possible.
FAQ List
It is planned that the Amendment 1 (A1) will have an IEC stability date up Amendment 1 is to ensure that the required safety of medical devices will
to 2019, meaning that no Amendment 2 is planned before 2019. If deemed be met in practice, among other issues. The EN 60601-1 3ed raised many
necessary from the point of safety, the additional requirements of the A1 issues among manufacturers and Notified Bodies alike concerning both the
may also be incorporated into the design of medical devices before the safety of medical devices and its implementation in Europe. The working
transition periods expire. group of the Notified Body NB-MED and the European Committee for
electrotechnical standardization CENELEC have addressed this issue and
Medical devices have been tested in accordance with the IEC 60601- prepared a list of FAQs concerning the 3ed. The intention behind this FAQ
1:2005 3ed. standard for roughly five years. Expiry of the transition periods document is to ensure a largely standardized approach by manufacturers,
in Europe and Canada has caused a sharp rise in the number of tests of Notified Bodies, testing and inspection organizations and approval
medical devices carried out in the testing laboratories of the Notified authorities. For an overview of the contents of the FAQ list log on
Bodies. In view of this development, the standard itself has been under to the last issue 1 of this newsletter of April 2012. n
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 contact
the standard was supplemented by Amendment 1:2012 which essentially Martin Schneeberg
reflects the state of the art. 89 5008-4476
+49
@ martin.schneeberg@tuev-sued.de

5. Vol. 2 September 2012
TÜV SÜD E-ssentials
Page 5
MEDDEV 2.12-1 rev. 7
Guidelines on a medical devices vigilance system updated
The guidelines on a medical devices vigilance system (MEDDEV • The example of incorrectly labelled in-vitro diagnostic devices in
2.12/1) have been updated and published as revision 7. This update Section 5.1.3.6 was deleted.
also supplies manufacturers with new Report Forms. An important • The list of examples of reportable incidents in Annex 1 was updated.
factor in this context is that manufacturers take note of the amended/
requested information in the Report Forms. A short summary of the The new MEDDEV forms are available here.
changes is provided below.
Annexes 3 and 4 to the guidelines now contain new Manufacturer‘s Incident contact
Report and Manufacturer’s Field Safety Corrective Action Report forms. Heiko Imhof
89 5008-4615
+49
The Annexes also include two new forms based on templates developed by @ heiko.imhof@tuev-sued.de
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”.

6. Vol. 2 September 2012
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International approvals: Russian Federation
Taking a shorter route on the long way east
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 conformity
The 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
To get their products approved for the Russian market, medical requirements of the applicable GOST-R series of standards. The declaration
devices manufacturers need two things: a certificate of registration of conformity is valid for a period of up to three years and can be issued
and a declaration of conformity. TÜV SÜD offers its clients both the exclusively to the local representative in the Russian Federation.
certificate of registration and the declaration of conformity as a full
service package. This article informs you about what is important Approval
for launching your products successfully on the Russian market. After both a certificate of registration and a declaration of conformity have
been issued, the respective medical device can be imported and placed on
In the Russian Federation, registration is effected by the “Federal Service on the Russian market.
Surveillance in Healthcare and Social Development” (Roszdravnadzor). Since
the EU and the Russian Federation have not signed a mutual agreement on Voluntary GOST-R certification
conformity assessment, medical devices approved in Europe cannot simply Depending on the medical device, numerous manufacturers apply for
be imported into the Russian Federation but must fulfill additional regulatory voluntary GOST-R-certification. The rationale behind their approach is that
requirements. To make matters even more complex, the requirements are the declaration of conformity replaced the GOST-R-certificate for many
only available in Russian, and Roszdravnadzor also expects communication medical devices as recently as 2011 and that the latter is still considered
and correspondence to be conducted in Russian. Many medical devices synonymous with premium quality in the Russian Federation. Given this,
manufacturers are inadequately prepared for these requirements – a costly voluntary certification may indeed be a good marketing and sales argument.
omission.
For the manufacturers of medical devices, it is of the essence that the
Step 1: Registration approval process goes smoothly and can be planned. TÜV SÜD is capable of
Medical devices manufacturers that want to export their products to handling this process from start to finish. Based on our profound knowledge
Russia must first designate a local representative. Successful registration, of the approval requirements and our fluency in Russian, we can ensure
confirmed by a certificate with unlimited period of validity, marks the first efficient approval of medical devices on behalf of manufacturers.
milestone on the way to market approval. The certificate of registration
is issued either to the manufacturer or its local representative, e.g. a
contact
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 Alexander Schapovalov
of these documents, for example the User‘s Manual or labelling, must be in 89 5008-4309
+49
Russian. Roszdravnadzor then thoroughly reviews this documentation. @
alexander.schapovalov@tuev-sued.de

7. Vol. 2 September 2012
TÜV SÜD E-ssentials
Page 7
International approvals: Australia
To Australia in five days with the MRA certificate
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 synergies
TÜV 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.
Exceptions
Australia is among the twelve richest countries in the world. Please take into account that the following medical devices are excluded
However, with only a handful of its own high-tech manufacturers, from the MRA:
the fifth continent depends on imports from other countries and
is thus an attractive market for medical devices. Its regulatory • Radioactive substances, in as far as these can be considered medical
authority is the TGA, which stands for Therapeutic Goods devices, and
Administration. This article explains how medical devices made • Medical devices that incorporate tissue of animal origin.
in Europe are approved for the Australian market. In addition, However, medical devices
we inform you what to look out for to launch your product on the a) incorporating refined derivatives of animal derived waxes,
Australian market within only five days. heparin and gelatine that conform to pharmacopoeial standards
and sintered hydroxyapatite or
Synergy effects are the “secret” of time and cost savings. In other words, b) incorporating tissues of animal origin, and where the device is
medical devices that have already been certified for the European market intended to come into contact with intact skin only,
can go on to use exactly the same technical documentation that was
required for certification there in order to gain market approval in Australia. are included within the scope of this Sectoral Annex.
This process is based on the Mutual Recognition Agreement (MRA) between
Australia and the European Union governing conformity assessments, For further information on MRA certification log on to: Link.
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 approval
The 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 contact
conformity with the Australian requirements, TÜV SÜD issues the certificate Georg Bauer
of conformity. The sponsor lodges the MRA certificate via the DEAL (Device 89 5008-4143
+49
Electronic Application Lodgement) online system, together with various @
georg.bauer@tuev-sued.de

8. Vol. 2 September 2012
TÜV SÜD E-ssentials
Page 8
IEC 62366/IEC 60601-1-6
Usability – still a challenge
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
The usability of medical devices ensures the safety of patients. device by, say, registered practitioners may differ from those of high-level
The trend that medical devices are becoming increasingly complex clients.
while many users are only inadequately trained and instructed in
their use causes an unfortunate imbalance. The EN 60601-1-6 and TÜV SÜD‘s auditors act on these incorrect processes. Some processes
EN 62366 standards establish a framework, showing manufacturers might have to be supplemented or even repeated, costing manufacturers
how to avoid this imbalance. Within the scope of medical devices a lot of time and money. In a worst-case scenario, involving systematic
certification, TÜV SÜD‘s experts repeatedly see the same mistakes violations, the certificate might have to be withdrawn. Given this, TÜV SÜD
in manufacturers‘ usability testing. However, what do manufacturers recommends that manufacturers focus usability testing on safety-critical
have to look out for if they do not want to jeopardize the market aspects before even commencing the test, prepare appropriate questions
approval of their devices? and select a representative group for the practice test.
The EN 60601-1-6 and the EN 62366 standards require rethinking on the Another aspect worth noting is that the requirements also apply to medical
part of medical devices manufacturers right from the design and development devices that are already established on the market. Another solution must
process. At this early stage in the process they must start to assess the be found for these devices to ensure their continued compliance with the
usability of their medical devices on an ongoing basis, aligning it with basic requirements of the Medical Devices Act in the future:
user requirements if necessary. This is done within the framework of a
documented usability engineering process in conformity with the standard. • Risk management should take care of potential usability risks.
During this process, the product will undergo practice testing in various • An effective system comprising customer complaints and surveillance
work processes and environments to identify possible sources of mistakes must be established.
and errors. The objective of the test method applied is firstly to ensure user • User feedback must be evaluated on an ongoing basis. The result of
satisfaction and, more importantly, to reach a level of safety that prevents this evaluation must then produce a sufficient level of safety.
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
contact
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 Dr. Andreas Purde
development process. In addition to the interview, TÜV SÜD recommends 89 5008-4203
+49
that manufacturers observe on-site how users handle the equipment. @ andreas.purde@tuev-sued.de

9. Vol. 2 September 2012
TÜV SÜD E-ssentials
Page 9
IEC 62653/ISO 9001
Good Dialysis Practice: documented quality and safety
Effective immediately, the recently individual concerned. By contrast, the IEC 62653 center: An institute certified by TÜV SÜD can
published international standard IEC 62653 “Guideline for safe operation of Medical Devices demonstrate documented safety and quality
together with ISO 9001 form the new basis used for haemodialysis treatments” focuses on standards, visualized to the public by the
of TÜV SÜD‘s “Good Dialysis Practice” prevention: the QM system must address known TÜV SÜD certification mark.
certificate, replacing the VDE 0753-4 2009-5 hazards and risks, including extracorporeal blood
standard only published in Germany. This loss, well in advance of commencing treatment Germany‘s Medical Devices Operators Regulation
voluntary certification scheme for dialysis procedures. In this context, the QM system states in Article 2 General Requirements: “(1)
centers assesses quality management (QM) defines preventive and corrective actions, thus Medical devices may only be operated, applied and
and preventive safety measures. Read here minimizing the risk faced by patients. Another maintained in line with their intended use, the
about the requirements that dialysis centers important element is a functioning culture of provisions of this regulation, the generally accepted
have to fulfill and how they can benefit from error. In concrete terms this means that any state of the art and occupational safety and health
voluntary certification. medical error that occurs must be analysed. and accident prevention regulations.” The “generally
Starting from this, preventive actions must be accepted state of the art” also includes the
TÜV SÜD has issued the “Good Dialysis Practice” identified which are incorporated into the QM IEC 62653 standard now published. n
certificate for the past eleven years. At present system and continuously improve the existing
the TÜV SÜD “Good Dialysis Practice” certification work processes.
mark is used by around 600 dialysis centers in 18
European countries, Turkey and South Africa with Benefits for patients and dialysis centers
a total of 12,500 staff. However, what criteria do Certification in accordance with TÜV SÜD‘s
dialysis centers have to fulfill to obtain this quality “Good Dialysis Practice” standard is voluntary.
label? To ensure that QM and safety go hand in However, why should dialysis centers voluntarily
hand, TÜV SÜD‘s experts verify compliance with undergo certification? Firstly, the QM system
two standards. The quality-system requirements helps them to improve in-house efficiency and
set forth in the ISO 9001 “Quality management transparency, and thus to avoid errors. Secondly,
systems – requirements” standard define the dialysis centers ensure compliance with all
framework of how the criteria for a functioning present and future legal requirements. Thirdly,
and effective safety culture – clear structures, certification provides medical centers with a
standardized work processes, appropriate certain level of assurance that they operate
contact
resources, effective communication structures – in compliance with the applicable laws. And,
can be established at the level of management. if an incident during analysis still results in a
Also important in this context is regular employee legal dispute with a patient, certification may Thomas Ludewig
training, which should be tailored to the level of have a mitigating effect on any penalty. Another 89 5008-4146
+49
knowledge and sphere of responsibilities of the important point is the public image of a dialysis @ thomas.ludewig@tuev-sued.de

10. Vol. 2 September 2012
TÜV SÜD E-ssentials
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IEC 60601-1-9
Environmentally conscious design of medical electrical equipment
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
The purpose of medical devices is to support equipment must be designed in accordance electrical equipment. In addition to these
the fight against diseases and save human with the relevant standards. This particularly fundamental issues, the course also gives tips
life. However, their functions and technical includes issues concerning the use and disposal on implementation in practice. Even though the
components may themselves pose risks for of toxic substances. Of course, the national various European directives on environmental
the environment and human health. Given this, requirements in non-European countries can vary protection require only a limited number of aspects
the international standard IEC 60601-1-9 is greatly. However, in most industrialized countries from the IEC 60601-1-9 standard for the sale of
designed to reduce the adverse environmental regulations can be assumed to be at least similar. products in Europe, manufacturers should inform
impacts of medical electrical equipment. themselves about all aspects. After all, compliance
The focus during design and production is 2. Conformity with standards with both the directives and client requirements
on functionality, usability and functional In some countries, the legal requirements may plays a major role in product success.
safety. However, the legal framework also demand evidence of conformity with certain
demands the inclusion of environmental environmental standards. While the law defines
protection aspects. In this context, the the general framework of environmental aspects,
requirements governing the environmental the standards provide specific information about
compatibility of medical devices concern all the implementation related to certain products.
phases of their life cycle. However, there are In the case of medical electrical equipment this
four important reasons why environmental is the IEC 60601-1-9 standard, an international
aspects should play a role right from the standard governing environmentally conscious
design and development stage of medical design of medical electrical equipment.
electrical equipment. Familiarity with this standard helps to take
all necessary environmental aspects into contact expert
1. Market access consideration in the design process. Michael Sippl
Market access is regulated by legal environmental 89 5008-4140
+49
protection requirements. In Europe these 3. Product/process improvement @ michael.sippl@tuev-sued.de
requirements are set forth in the following Consideration of environmental aspects improves
contact seminar
directives, now transposed into national laws: not only products, but also the product-related
ROHS, WEEE, REACH etc.The standard addresses design and production processes. By reducing
the various EU directives in detail to identify certain materials in the device and the use of, Birgit Klusmeier
possible requirements for product design. say, energy or resources, savings may be realized + 9 89 5791-3306
4
To stand a chance later on the European market, for both manufacturers and users. @ birgit.klusmeier@tuev-sued.de

11. Vol. 2 September 2012
TÜV SÜD E-ssentials
Page 11
Med-Info
Regular Information Bulletins for the Medical Device Industry
TÜV SÜD provides you with exclusive • Chinese Approval for Medical Devices 2007/47/EC
comprehensive information on a host of topics – • FDA 510(k) • Human Blood Derivatives
free of charge! • Globalization of Medical Device Approval • Material of Animal Origin
• Japanese PAL • Medical Devices utilizing Material of
Standards EU Guidelines • PAL – Change Application and Notification Animal Origin
• Council Directive 93/42/EEC • PAL – Fundamental Info • Tools for Tissue Engineering
• Design Dossiers • PAL – Maintain Approvals/Certificates
• Extension of EC Certificates • PAL – MHLW Movement F
urther Services
• IEC 60601-1:2005: 3rd Edition • PAL – Transitional Measures for Approved • EN 60601-2-5 Therapeutic Ultrasound
• IVD Directive 98/79/EC Medical Devices Devices
• Revision of MDD 93/42/EEC • EN 60601-2-37 Diagnostic Ultrasound
• Transition from 2nd Edition to 3rd Edition of Clinical Affairs Devices
IEC/EN 60601-1:2005 • Advanced Therapy Medicinal Products • Medical Device Software
• Transition to EC Directive 2007/47/EC • Assessment of Medical Devices • Quality Management in Dialysis
• Usability of Medical Devices Incorporating Material of Animal Origin
• Biological Evaluation Partially available also in German
I
nternational Affairs • Biological Safety
• Access Australia • Clinical Data Requirements for EC Download our free information from
• Access Russian Federation Certificate Extension www.tuev-sued.com/medinfo.
• Access USA and Canada • Clinical Data Requirements in Era of
Your medical device contacts worldwide
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