Title: An Introduction to Medical Device Regulation in the European Union
1An 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.
3European Union
Austria Belgium Denmark Finland France Germ
any Greece Ireland Italy Luxembourg Netherlan
ds
Portugal Spain Sweden U.K.
4European Economic Area
EU Ireland Norway Liechtenstein
5Why come to Europe?
6Area, population, and estimated population growth
7Purchasing power
U.S.A.
E.U.
8The EU is
- Poland
- Hungary
- Czech Republic
- Slovenia
- Estonia
- Cyprus
- Romania?
- Bulgaria?
- Lithuania?
- Latvia?
- Slovakia?
9EU 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
10CE-Marking as Insurance
FDA says NO!
510K PMA IDE
11Harmonization 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
13Status of EU Medical Device Laws
- AIMD Fully in effect
- MDD Transition period ends on 6/14/98
- IVDD ?
Exemption for pipeline product
14By the end of the applicable transition period,
all devices subject to the three laws must have
obtained the right to bear the CE-Marking
15What 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
16Obtaining 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
17Conformity 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.
18Examples of Notified Bodies
- BSI (British Standards Institite)
- TÜV Product Service GMBH Munich
- TÜV Product Service GMBH Rhineland
- AMTAC
- Lloyds Registry
19Role 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.)
21Why 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
22What 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
23Is use of standards mandatory under the MDD and
AIMD?
NO!
24Am 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
25What 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
26What 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
27Role 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
29Need 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
31Benefits 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
32Importance of Understanding the Interrelationship
Between the Annexes to the AIMD and the MDD
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38Class 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
39Class 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
40AIMD Medical Devices
- High risk devices so same alternatives as Class
III medical devices under the MDD
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42Some myths to dispel about Europe
43There is no such thing at present as a European
44The AIMD and the MDD have, or will completely
harmonize, regulation of medical devices in the EU
45The 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
46If 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
47The hard way vs. the easy way of coming to
Europe
HARD
EASY
48The 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.
49The 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.
50The 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.
51Hot Issues