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)
Date: 2005-08-11
Institutions: European Commission
Subjects: facilities for people with disabilities, marketing, medical device, standardisation

12.8.2005

EN

Official Journal of the European Union

L 210/41

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
Community,

establishing the European

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)

(2)

(3)

(4)

(5)

(6)

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.

France and the United Kingdom requested the classifi-
cation 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 repla-
cements before their placing on the market.

Conformity assessment is based on a number of elements
such as a proper classification, the designation and moni-
toring of the notified bodies and the proper implemen-
tation of the conformity assessment modules as described
in Directive 93/42/EEC.

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.

Hip, knee and shoulder replacements should be distin-
guished 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.

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)

(8)

(9)

(10)

(11)

Shoulder implants are a more recent technique, which
are subject to similar dynamic forces; their possible repla-
cement is in principle connected with serious medical
problems.

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.

always

for hip, knee

Specific clinical data,
including long term performance
and
available
are not
data
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 charac-
teristics 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.

Total joint replacements can be subject to multiple modi-
fications following their introduction into clinical use and
placing on the market, as shown by hip and knee repla-
cements on the market. However, experience has shown
that what appear at
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.

sight

first

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 manufac-
turing 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 exam-
ination 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.

(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).

(13)

For these reasons, it is necessary to proceed to the reclas-
sification of hip, knee and shoulder total
joint repla-
cements as class III medical devices.

L 210/42

EN

Official Journal of the European Union

12.8.2005

(14)

It is necessary to provide for an adequate transitional
period for hip, knee and shoulder total
joint repla-
cements 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)

that have

already been subject

It is necessary to provide for an adequate transitional
period for hip, knee and shoulder total
joint repla-
to the
cements
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.

Article 3

Hip, knee and shoulder

to a conformity assessment procedure pursuant

replacements that have been
1.
subject
to
Article 11(3)(a) of Directive 93/42/EEC before 1 September
conformity
2007 shall be
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 manu-
conformity
facturer
assessment based on Article 11(1)(b) of Directive 93/42/EEC.

an application for

from submitting

complementary

subject

to a

Hip, knee and shoulder

to a conformity assessment procedure pursuant

replacements that have been
2.
subject
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 manu-
facturer
conformity
assessment based on Article 11(1)(a) of Directive 93/42/EEC.

an application for

from submitting

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.

(17)

in this Directive are in
The measures provided for
the Committee on
accordance with the opinion of
Medical Devices
set up by Article 6(2) of Council
Directive 90/385/EEC of 20 June 1990 on the approx-
imation of the laws of the Member States relating to
active implantable medical devices (1),

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.

HAS ADOPTED THIS DIRECTIVE:

Article 4

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 repla-
cement 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. Ancillary components
joint or
(screws, wedges, plates and instruments) are excluded from
this definition.

a natural

shoulder

1. Member States shall adopt and publish the laws, regu-
lations 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.

(1) 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.

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.

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Official Journal of the European Union

L 210/43

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