IT’S THE LAW
New Developments in European Medical
Device Law
By Philipp Reusch
European medical device law is uniformly
harmonized across the individual Member
States of the EU, although it is continually
subject to amendments, which are significant
in practical terms, and there are national
variants. This article introduces applicable
regulations, illustrates the main reforms
brought about by the directive amendment
and discusses liability law relating to the
importation of goods into the EU.
• Council Directive 90/385/EEC of 20
June 1990 on the approximation of the
laws of the Member States relating to
active implantable medical devices
• European Parliament and Council
Directive 98/79/EC of 27 October 1998
relating to in vitro diagnostic devices
In accordance with the concept of the New
Approach, these directives are currently
augmented1 by 308 standards.
Overview of Applicable Law
Changes in the New Approach—the
New Legislative Framework
European regulations on medical devices
are contained in several directives and ordinances. These include:
• European Parliament and Council
Directive 2007/47/EC of 5 September
2007 on the amendment of Council
Directives 90/385/EEC on the approximation of the laws of the Member
States relating to active implantable
medical devices and 93/42/EEC concerning medical devices
• Council Directive 93/42/EEC of 14
June 1993 concerning medical devices
• European Parliament and Council
Directive 2000/70/EC of 16 November
2000 on the amendment of Council
Directive 93/42/EEC with regard to
medical devices containing stable derivates of human blood or human plasma
• European Parliament and Council
Directive 2001/104/EC of 7 December
2001 on the amendment of Council
Directive 93/42/EEC concerning medical devices
• Commission Directive 2003/32/EC of
23 April 2003 with precise specifications
relating to the requirements laid down
in Council Directive 93/42/EEC regarding medical devices manufactured
using tissue of animal origin
At present, many of the provisions of these
directives are undergoing changes, including the New Approach concept itself. The
aim of the concept,2 introduced in 1985,
was the technical harmonization of certain
products and thus the promotion of trade
within the EU. The objective was to allow
manufacturers as much autonomy as possible in the manufacture of their products.
Government control was to apply mainly to
monitoring products already on the market.
Apart from that, government oversight was
only considered in the case of products with
a particularly high risk potential. At the
same time, the objectives of guaranteeing
citizens’ safety and health and protecting
the consumer were pursued.
The New Approach has been revised by
the decision of the European Parliament and
the Council of the European Union,13 the
new legislative framework. The new concept provides the general framework and
model conditions for revising existing directives and creating new ones. Further, the
market surveillance regulations have been
tightened and new regulations for accrediting of conformity assessment bodies have
been created.14
The updated New Approach concept
comprises the following basic principles:
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49
• Harmonization is restricted to essential
safety requirements and does not go
into detail.3 Indeed, due to technical
progress and the large number of technical rules, full harmonization would
hardly be possible. This system is considerably more flexible than continual
revision of the directives. By means of
the essential safety requirements, the
directives define the desired result with
regard to product safety. They do not
stipulate the path that has to be taken
to achieve that result.
• Only products that satisfy the essential
safety requirements may be marketed.
• The technical details are not elaborated upon in the directives by the
institutions of the EU, but rather
by the European Committee for
Standardisation (CEN), the European
Committee for Electrotechnical
Standardisation (CENELEC) and
the European Telecommunications
Standards Institute (ETSI). This principle of the division of work was
introduced for the first time as part of
the New Approach.4
• There is a rebuttable presumption that
products manufactured in compliance
with the harmonized standards satisfy
the essential safety requirements.5
• The application of the harmonized
standards remains voluntary for the
manufacturer. In a legal sense, the
requirements of the directive concerned
are decisive. The product manufacturers
are only obliged to satisfy the essential
safety requirements laid down in the
directives.6 This opens up to the manufacturer the possibility of manufacturing
its product in a way that departs from
the harmonized standards, using innovative technologies. That being said, the
presumption of conformity as regards
compliance with the harmonized standards does not apply here.
The New Approach is complemented by the
Global Concept of Certification and Testing,
50
July 2009
which addresses the mutual recognition of
product tests. Basically, the Global Concept
governs the conformity assessment procedure and certification.
Meanwhile, since 1987, more than
20 directives have been issued based on
the New Approach and Global Concepts,
among them the better-known directives
on machinery7 and medical devices.8 We
must differentiate here between riskspecific (so-called “horizontal”) directives
and product-specific (so-called “vertical”)
directives. Horizontal directives cover various groups of products that pose a single,
specific risk, for example, the low voltage
directive.9 Vertical directives refer only to
a single product group that poses various
different risks. Examples are the Recreational
Craft Directive,10 the Lifts Directive,11 the Toy
Directive12 and the Medical Devices Directive.
Amendments to the Medical Devices
Directive Brought About by Directive
2007/47/EC
Parallel to these developments, Directive
2007/47/EC15 laid down an amendment
to the medical device regulations in EU
Member States. The Member States were
required to convert the directive into
­national law16 by 21 December 2008 and it
takes effect beginning 21 March 2010.
The amendments are remarkable in several ways:
• Software qualifies as a medical device.
• Devices that are also machines within
the meaning of Directive 2006/42/EC
must also satisfy these requirements.
• Not only active implants but also
medical devices must, as a general rule,
undergo a clinical assessment that can,
under certain circumstances, also be
taken from the scientific literature.
• Repeat evaluations of the clinical tests
are to be kept up to date as part of the
postmarket clinical follow-up.
These obviously new provisions in
the directive and the national laws are
complemented by many others whose newness may be less obvious. One of these is
a change in the conditions applying to the
designation of authorized representatives.
Changes for Non-European
Manufacturers
In the old Medical Devices Directive, manufacturers located outside the EU were under
an obligation to designate an Authorised
Representative within the EU who could
exercise the manufacturers’ rights and fulfill
their obligations within the framework of
the directive. As a rule, this role was undertaken by a consulting firm, which was in a
position to assist the manufacturer in the
fulfillment of regulatory requirements.
According to the new definition
set forth in Directive 2007/47/EC,17
the Authorised Representative is “any
natural or legal person established in the
Community who, explicitly designated
by the manufacturer, acts and may be
addressed by authorities and bodies in the
Community instead of the manufacturer
with regard to the latter’s obligations under
this Directive.”
In addition, Article 13 states:
“Where a manufacturer who places a
device on the market under his own name
does not have a registered place of business in a Member State, he shall designate
a single Authorised Representative in the
European Union.”
These two provisions are currently causing
a good deal of uncertainty, not only among
companies whose registered offices are outside the EU and who wish to export to the
EU, but also among those wishing to market
these products within the EU.
They beg the question of who is to bear
responsibility in terms of product liability law and also from a regulatory point
of view, what the repercussions will be if
no Authorised Representative has been
designated or, for example, if more than
one Authorised Representative has been
designated.
According to product liability law, which
is regulated uniformly across Europe, the
importer of a product is liable if he cannot,
within a certain period, name the manufacturer whose registered office is outside the EU.
In addition, the Authorised Representative is
liable if he labels the imported products with
a brand name of his own.
These scenarios, which were already
provided for before the amendments to the
medical devices directive, now form a volatile mixture. The importer of a medical device
is well out of the limelight in product liability terms if an Authorised Representative
fulfills the obligations of a non-European
manufacturer and the importer can name
that individual as the manufacturer’s representative. However, according to the new
regulations, if circumstances arise in which
no Authorised Representative has been
effectively designated, the importer must not
expect to be able to pass on liability to the
representative or manufacturer. The German
Medical Devices Act (MPG) also makes this
assumption, as §5 shows:
“The person responsible for the first
placing on the market of the device is
the manufacturer or his/her Authorised
Representative. If the manufacturer does not
have his/her registered place of business
in the European Economic Area and if an
Authorised Representative has not been designated, or if medical devices are not being
imported into the European Economic Area
under the responsibility of the Authorised
Representative, the importer shall be the
person responsible. The name or the firm
and the address of the person responsible
must appear on the label or in the instructions for the use of the medical devices.”18
The picture is similar in terms of product
safety law. Without the effective designation
of a single Authorised Representative, obligations that the Authorised Representative
would otherwise be required to fulfill may be
incumbent upon the importer, who intends
merely to trade in the products. These obligations may include providing information
to the market surveillance authorities, or
Regulatory Focus
51
participating in the market surveillance
system or in measures ordered by the
authorities such as warnings or recalls. In all
cases, the real raison d’être of the legal concept is to ensure that a contact—in the form
of the Authorised Representative—is available in the EU in lieu of the manufacturer.
If, however, the appointment of an
Authorised Representative is unsuccessful,
the consequences for all those involved in
terms of product liability and product safety
law are obvious.
At present, this situation is particularly
likely to crop up in relations with Turkey.
Turkey is not yet a member of the EU or the
European Economic Area (EEA), but it has
bound itself to the provisions of medical
products law by means of a treaty of accession19 and certain other laws. Thus, Turkey
has enacted a law that implements the subject matter of the Medical Devices Directive.
For legislative reasons, Turkey was obliged
to adopt a provision under which anyone
importing into Turkey required a Turkish
Authorised Representative. In principle, this
provision served to implement the European
regulations, but fell short of actually having
any effect—except in interaction with the
abovementioned treaty of accession—because
Turkey was not yet a Member State. It should
be made clear that Turkey intended to allow
products that had been imported into the EU
via a representative other than the Turkish
Authorised Representative to be traded in
freely. That being said, because of the lack of
clarity in the provisions in the Turkish law
and a degree of ignorance of the effects of the
treaty of accession, a non-European importer
may resort to designating an Authorised
Representative in Turkey in addition to the
one he has designated for the EU. If he does
that, the problems already outlined above
connection with the new amendment of
Article 11 of the directive may arise.
A non-European manufacturer can circumvent these problems if, in spite of access to
the Turkish market, it designates exclusively a
Central European Authorised Representative
to cover both Turkey and the EU.
52
July 2009
References
1. A complete overview is available at www.eg-richtlinien-online.de under Medizinprodukterichtlinie.
2. Council decision of 7 May 1985, O.J. 1985 C 136/1.
3. Kapoor A, Klindt T. “New Legislative Framework
in EU product safety law—new market surveillance
in Europe.” European Commercial Law Magazine
(EuZW). 19:649,650 (2008).
4. Krieger S. “The technical environmental law of
the Community according to the ‘New Concept’”.
Environmental and planning law (UPR). 12:401
(1992).
5. Klindt T. “Consumer protection by the integration
of safety law requirements in the design of appliances and devices.” Consumers and the law (VuR).
16:394,396 (2001).
6. Scheel K-C. “Interpretation of EU directives and the
competence of the Commission to decide.” Trade
and industry archive (GewArch). 45:129,130 (1999).
7. EC Directive 2006/42 of 17 May 2006, O.J. 2006 L
157/24.
8. EC Directive 2007/47 of 5 September 2007, O.J.
2007 L 247/21.
9. EC Directive 2006/95 of 12 December 2006, O.J.
2006 L 374/10.
10. EC Directive 1994/25 of 16 June 1994, O.J. 1994 L
164/15.
11. EC Directive 1995/16 of 29 June 1995, O.J. 1995 L
213/1.
12. Ibid 5.
13. Decision 768/2008 of 9 July 2006, O.J. 2008 L
218/82.
14. EC Regulation 765/2008 of 9 July 2006, O.J. 2008 L
218/30.
15. To be more precise: European Parliament and
Council Directive 2007/47/EC of 5 September 2007
on the amendment of Council Directives 90/385/
EEC on the approximation of the laws of the member states relating to active implantable medical
devices and 93/42/EEC concerning medical devices, and Directive 98/8/EC concerning the placing
on the market of biocidal products.
16. Following this the German Medical Products Act
was amended by the German legislators. The new
version is available at http://bundesrecht.juris.de/
bundesrecht/mpg/index.html.
17. Article 1 a III
18. Translation of this paragraph copied from www.
bmg.bund.de.
19. Resolution 1/95 of the European Commission.
Author
Philipp Reusch is a founder and equity partner
of the international commercial law firm Reusch
Rechtsanwälte GbR. He has published widely, including the Handbook of Product Liability and lectures at
Cologne’s University of Applied Sciences on product
liability law. Reusch can be reached at p.reusch@
reuschlaw.de.