Commission Directive 2005/50/EC of 11 August 2005 on the
reclassification of hip, knee and shoulder joint replacements in the framework
of Council Directive 93/42/EEC concerning medical devices (Text with EEA
relevance)
Official Journal L 210 , 12/08/2005 P. 0041 -
0043
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the
framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices [1], and in particular Article 13(1)(b) thereof, Having regard to the request submitted by France and the United Kingdom, Whereas: (1) On the basis of the classification rules set out in Annex IX to Directive
93/42/EEC, total joint replacements are class IIb medical devices. (2) France and the United Kingdom requested the classification of total joint
replacements as class III medical devices by way of derogation from the
provisions of Annex IX to Directive 93/42/EEC, in order to ensure an appropriate
conformity assessment of total joint replacements before their placing on the
market. (3) Conformity assessment is based on a number of elements such as a proper
classification, the designation and monitoring of the notified bodies and the
proper implementation of the conformity assessment modules as described in
Directive 93/42/EEC. (4) Reclassification by derogation to the classification rules set out in
Annex IX to Directive 93/42/EEC is indicated where the shortcomings identified
due to the specific characteristics of a product will be more properly addressed
under the conformity assessment procedures corresponding to the new
category. (5) Hip, knee and shoulder replacements should be distinguished from other
total joint replacements, due to the particular complexity of the joint function
to be restored and the consequent increased risk of failure due to the device
itself. (6) In particular, hip and knee replacements are weight-bearing and extremely
sophisticated implants, for which the risk of revision surgery is significantly
greater than for other joints. (7) Shoulder implants are a more recent technique, which are subject to
similar dynamic forces; their possible replacement is in principle connected
with serious medical problems. (8) Furthermore, hip, knee and shoulder replacement surgery is increasingly
taking place on young people with a high life expectancy; consequently, the need
for such implants to function properly over the life expectancy of the patients
and to reduce revision surgery and its risks has been increased. (9) Specific clinical data, including long term performance data are not
always available for hip, knee and shoulder replacements before they are placed
on the market and put into service; consequently, conclusions on clinical data
collected by the manufacturer in the framework of the evaluation of the
conformity of these products with the requirements concerning their
characteristics and performance referred to in Sections 1 and 3 of Annex I to
Directive 93/42/EEC should be subject to particular attention and examination in
order to verify the appropriateness of the clinical data available. (10) Total joint replacements can be subject to multiple modifications
following their introduction into clinical use and placing on the market, as
shown by hip and knee replacements on the market. However, experience has shown
that what appear at first sight to be minor post-marketing changes to the design
of previously trouble-free replacements can lead to serious problems due to
unintended consequences, which may lead to early failure and major safety
concerns. (11) In order to achieve the optimal level of safety and health protection
and to reduce the design related problems to the lowest level, the design
dossier of hip, knee and shoulder replacements, including the clinical data used
by the manufacturer to support the claimed performance and the subsequent
post-marketing design and manufacturing changes should be examined in detail by
the notified body before these devices are introduced in general clinical
use. (12) Consequently, the notified body should, under the full quality assurance
system, effectively carry out an examination of the design dossier and of the
changes to the approved design in accordance with point 4 of Annex II to
Directive 93/42/EEC. (13) For these reasons, it is necessary to proceed to the reclassification of
hip, knee and shoulder total joint replacements as class III medical
devices. (14) It is necessary to provide for an adequate transitional period for hip,
knee and shoulder total joint replacements already assessed as class IIb medical
devices under the full quality assurance system of Annex II to Directive
93/42/EEC, allowing for their complementary assessment under point 4 of Annex II
to the Directive. (15) Hip, knee and shoulder total joint replacements already certified
following the procedure relating to the EC type examination set out in Annex III
to Directive 93/42/EEC, coupled with the procedure relating to the EC
verification set out in Annex IV or the procedure relating to the EC declaration
of conformity set out in Annex V to that Directive, are not affected by the
present Directive as these certification schemes are the same for both class IIb
and class III medical devices. (16) It is necessary to provide for an adequate transitional period for hip,
knee and shoulder total joint replacements that have already been subject to the
procedure relating to the EC type examination under Annex III to Directive
93/42/EEC coupled with the procedure relating to the EC declaration of
conformity set out in Annex VI to that Directive, allowing for their assessment
under Annex IV or Annex V to Directive 93/42/EEC. (17) The measures provided for in this Directive are in accordance with the
opinion of the Committee on Medical Devices set up by Article 6(2) of 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 [2], HAS ADOPTED THIS DIRECTIVE: Article 1 By way of derogation from the rules set out in Annex IX to Directive
93/42/EEC, hip, knee and shoulder replacements shall be reclassified as medical
devices falling within class III. Article 2 For the purpose of this Directive, a hip, knee or shoulder replacement means
an implantable component part of a total joint replacement system which is
intended to provide a function similar to that of either a natural hip joint, a
natural knee joint or a natural shoulder joint. Ancillary components (screws,
wedges, plates and instruments) are excluded from this definition. Article 3 1. Hip, knee and shoulder replacements that have been subject to a conformity
assessment procedure pursuant to Article 11(3)(a) of Directive 93/42/EEC before
1 September 2007 shall be subject to a complementary conformity assessment under
point 4 of Annex II to Directive 93/42/EEC leading to an EC design examination
certificate before 1 September 2009. This provision does not preclude a
manufacturer from submitting an application for conformity assessment based on
Article 11(1)(b) of Directive 93/42/EEC. 2. Hip, knee and shoulder replacements that have been subject to a conformity
assessment procedure pursuant to Article 11(3)(b)(iii) of Directive 93/42/EEC
before 1 September 2007 may be subject to a conformity assessment as class III
medical devices pursuant to Article 11(1)(b)(i) or (ii) before 1 September 2010.
This provision does not preclude a manufacturer from submitting an application
for conformity assessment based on Article 11(1)(a) of Directive 93/42/EEC. 3. Member States shall accept until 1 September 2009 the placing on the
market and the putting into service of hip, knee and shoulder replacements
covered by a Decision in accordance with Article 11(3)(a) of Directive 93/42/EEC
issued before 1 September 2007. 4. Member States shall accept until 1 September 2010 the placing on the
market of hip, knee and shoulder replacements which are covered by a Decision in
accordance with Articles 11(3)(b)(iii) of Directive 93/42/EEC issued before 1
September 2007 and permit such total joint replacements to be put into service
beyond that date. Article 4 1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive not later than
1 March 2007. They shall immediately inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to
this Directive or shall be accompanied by such a reference at the time of their
official publication. Member States shall determine how such a reference is to
be made. Member States shall apply those provisions from 1 September 2007. 2. Member States shall communicate to the Commission the texts of the
provisions of national law which they adopt in the field covered by this
Directive. Article 5 This Directive shall enter into force on the 20th day following that of its
publication in the Official Journal of the European Union. Article 6 This Directive is addressed to the Member States. Done at Brussels, 11 August 2005. For the Commission Günter Verheugen Vice-President [1] OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ L 284,
31.10.2003, p. 1). [2] OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council. --------------------------------------------------