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An Introduction to Medical Device Regulation in the European Union

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Title: An Introduction to Medical Device Regulation in the European Union


1
An Introduction to Medical Device Regulation in
the European Union
  • Jill B. Deal
  • Fish Richardson p.c.

2
  • Europe is a general term which does not an
    accurate definition of the geographic area
    covered by the term.
  • TIP Learn what the accurate terms mean and use
    them.

3
European Union
Austria Belgium Denmark Finland France Germ
any Greece Ireland Italy Luxembourg Netherlan
ds
Portugal Spain Sweden U.K.
4
European Economic Area
EU Ireland Norway Liechtenstein
5
Why come to Europe?
6
Area, population, and estimated population growth
7
Purchasing power
U.S.A.
E.U.
8
The EU is
  • Poland
  • Hungary
  • Czech Republic
  • Slovenia
  • Estonia
  • Cyprus
  • Romania?
  • Bulgaria?
  • Lithuania?
  • Latvia?
  • Slovakia?

9
EU Medical Device Laws as a Worldwide Regulatory
Paradigm
  • Mutual Recognition
  • Australia, EEA, Switzerland, some Central
    European Countries
  • Abbreviated applications for EU-approved devices
  • China, Canada, Asean countries, Korea
  • Amending systems to EU-type systems
  • Canada, Australia, Korea

10
CE-Marking as Insurance
FDA says NO!
510K PMA IDE
11
Harmonization of medical devices will be achieved
by three laws in the EU
12
  • Active Implantable Medical Devices Directive, 90
    1385/EEC, 1990 O.J. (L. AIMD 189) 17
  • Medical Devices Directive (MDD), 93/42/EEC,
    1993 O.J. (L189)1
  • In Vitro Diagnostic Medical Devices (IVDD),
    (199_O.J.(L__)_April 1, 1998

13
Status of EU Medical Device Laws
  • AIMD Fully in effect
  • MDD Transition period ends on 6/14/98
  • IVDD ?

Exemption for pipeline product
14
By the end of the applicable transition period,
all devices subject to the three laws must have
obtained the right to bear the CE-Marking
15
What will happen if my device is not CE-Marked by
the end of the applicable transition period?
  • Seizure
  • Fines
  • Criminal penalties
  • No sales until obtains right to bear CE-Marking

16
Obtaining the CE-Marking
  • Classification according to risk, class I being
    the lowest, class III being the highest
  • Classification will determine the conformity
    assessment options which a manufacturer may use
    to bring its product into conformity with the
    essential requirements of the applicable EU laws

17
Conformity assessment options may require the
services of a Notified Body -- testing and
certification organizations which have been
formally notified by the EU Commission as
competent for the purposes of assessing
conformity with the applicable conformity
assessment option.
18
Examples of Notified Bodies
  • BSI (British Standards Institite)
  • TÜV Product Service GMBH Munich
  • TÜV Product Service GMBH Rhineland
  • AMTAC
  • Lloyds Registry

19
Role of standards in achieving compliance with
the essential requirements of the MDD and AIMD
20
  • Standards are a critical part of the process to
    achieve compliance with the essential
    requirements of the MDD and AIMD that will permit
    a company to put the CE-Marking on its devices.
  • Any kind of standards that can be used to achieve
    conformity with the essential requirements of the
    MDD and AIMD but there is a descending order of
    preference depending upon the identity of the
    organization that promulgated the standard.

EN member state standards (BS, DIN, AFNOR) int
ernational standards (ISO, IEC, etc.)
21
Why are ENs the most highly preferred?
  • They are harmonized standards promulgated by
    CEN or CENELEC, the European standards setting
    organizations, in response to Commission mandates
  • They come in three (3) levels
  • Level 1 horizontal (EN 46,000 series)
  • Level 2 semi-horizontal/semi-vertical
  • Level 3 vertical (cardio-vascular catheters)
  • When published by the Commission of the EU in the
    Official Journal (equivalent to our Federal
    Register), member states are obliged to
    promulgate the standard into a national standard
    word for word identically to the text published
    in the Official Journal
  • The result is an identical standard in place
    EU-wide

22
What are the companys incentives for reliance
upon EU standards?
  • Reliance upon an EN standard creates a
    presumption of conformity to the essential
    requirements of the relevant parts of the MDD and
    the AIMD to which the standard relates.
  • They are SUPERSTANDARDS

23
Is use of standards mandatory under the MDD and
AIMD?
NO!
24
Am I likely to find an EN standard or other
non-harmonized standard suitable for meeting all
of the essential requirements under the MDD and
AIMD?
Probably Not
25
What do I do if there is no existing standard in
force for one or more of the essential
requirements applicable to my medical devices?
  • Build on an existing standard
  • Use of non-standard based evidence to fill gaps
  • Consult your Notified Body and follow its advice

26
What does prEN mean and does this affect a
standards utility to me for conformity
assessment purposes
  • prENs are ENs in draft form and are therefore
    subject to further change
  • Probably usable if in fairly final form, but
    consult your Notified Body before relying on them

27
Role of ISO 9000 Standards
28
  • Important to understand that compliance with ISO
    9000 series of standards alone will not mean that
    the company automatically obtains the right to
    put the CE-Marking on its devices
  • ISO 9000 as a TOOL to use to achieve compliance
    with the ESSENTIAL REQUIREMENTS of the MDD and
    AIMD
  • Need to add on parts such as graphic symbols (BS
    EN 980), labeling (BS prEN 1041), risk analysis
    (BS prEN 1441)
  • Need to focus on the ESSENTIAL REQUIREMENTS of
    the MDD and AIMD that will apply to your
    companys devices

29
Need to put the conformity assessment process
into perspective
  • CE-Marking will involve on-going compliance
    obligations
  • Need to choose the right Notified Body for your
    company based upon not only its short term but
    also its long-term needs
  • Need to make sure that the classification of your
    devices is correct to ensure that the conformity
    assessment procedure that your company uses is
    the most appropriate to your device without
    creating undue and necessary costs and burdens

30
  • Likelihood that, due to the regulatory structure
    established by the MDD and AIMD, the two
    directives are likely to be interpreted slightly
    differently from member state to member state
  • Need to shop for a regulatory culture that your
    company will feel comfortable with over not only
    the short but also over the long-term
  • Need to interview the competent authority,
    several Notified Bodies and consultants before
    choosing the culture that will best serve your
    company
  • German example

31
Benefits of coming to EU and interviewing several
different regulatory cultures before deciding
upon a Notified Body
  • Classification decisions may be different, which
    could make a big difference in compliance
    costs/burdens, long and short term
  • Burden of compliance audits IX/year vs 2X yr
  • Degree of flexibility in responding to need to
    make a change either to the device or the process
    for designing/manufacturing the device
  • How user friendly is the Notified Body likely to
    be?
  • Benefits of having consultants fully familiar
    with the essential requirements of the MDD and
    the AIMD before choosing a Notified Body,
    particularly where the classification for a
    device may not be clear

32
Importance of Understanding the Interrelationship
Between the Annexes to the AIMD and the MDD
33
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38
Class I Devices
  • Includes most medical devices
  • Burden for conformity assessment put on
    manufacturer who is responsible for making the
    declaration of conformity that will permit the
    CE-Marking to be put on a device
  • NO involvement by Notified Body except for
    aspects of a device relating to sterility or a
    measuring function
  • Notified Body has NO competence under MDD to
    perform conformity assessment on Class I devices
    except to extent such features relate to
    sterility or measurement

39
Class I Devices (cont.)
  • Notified Body CANNOT let its identity number be
    placed on a Class I device except to indicate its
    involvement with sterility/measurement functions
  • No authority of Notified Body under MDD to do
    spot checks of declaration
  • NO need for ISO/EN 9000 anything on Class I
    devices
  • Conformity assessment for Class I devices is not
    meant to create big costs or burdens because
    these are regarded as low risk devices

40
AIMD Medical Devices
  • High risk devices so same alternatives as Class
    III medical devices under the MDD

41
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42
Some myths to dispel about Europe
43
There is no such thing at present as a European
44
The AIMD and the MDD have, or will completely
harmonize, regulation of medical devices in the EU
45
The AIMD and MDD are both prime examples of
important cultural differences between member
states in the EU
  • Germany - longstanding reliance upon testing
  • United Kingdom - longstanding reliance upon
    quality systems

46
If you have ISO 9000 in place, you automatically
get your CE-Marking
  • ISO 9000 is a TOOL to achievement of conformity
    with the ESSENTIAL REQUIREMENTS of the MDD and
    the AMD

47
The hard way vs. the easy way of coming to
Europe
HARD
EASY
48
The Hard Way
  • But the FDA said
  • In the U.S., they do it this way
  • But Ive got IRB approval in the States.
  • I assume the law is the same in Europe as it is
    in the States, so
  • But everybody over there uses two-page
    contracts
  • If they dont do things like we do in the States
    - they ought to, so well do it the way we do in
    the States anyway.
  • But this wasnt an issue in the IDE.

49
The Easy Way
  • Respect cultural differences in Europe.
  • Dont assume that the laws and practices are the
    same in member states of the EU as they are in
    the U.S.
  • Choose a regulatory regime that fits in best with
    your culture.
  • Listen carefully for mistakes in translation.
  • Dont be afraid to call upon experts for their
    interpretations.

50
The Easy Way (cont.)
  • Shop carefully for your Notified Body as it is a
    decision you will likely have to live with for
    the rest of your life at your company.
  • Make sure you have got the classification of your
    device right before you begin spending
    substantial amounts of money on obtaining your
    CE-Marking.
  • Dont set regulatory goals/deadlines that will be
    impossible to accomplish because of the calendar
    in Europe.

51
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