WRITTEN QUESTION E-3374/03 by John Bowis (PPE-DE) to the Commission. Reclassification of hip, knee and shoulder joint replacements.
Date: 2003-11-14
Institutions: European Parliament, Provisional data
Subjects: medical device, product safety, public health, scientific report, technical regulations

20.3.2004

EN

Official Journal of the European Union

C 70 E/261

(2004/C 70 E/281)

WRITTEN QUESTION E-3374/03

by John Bowis (PPE-DE) to the Commission

(14 November 2003)

Subject: Reclassification of hip, knee and shoulder joint replacements

Has the Commission assessed the scientific justification for its possible forthcoming proposal to reclassify
hip, knee and shoulder replacement devices as Class III medical devices under Directive 93/42/EEC (1) (total
joint replacements are currently classified as Class II b under this Directive), and, in particular, evidence
that might link accidents with such replacement devices with their design? Has the Commission considered
all available studies and the effects of a reclassification on costs, availability and innovation, and what
conclusions has it drawn? In particular, is it aware of the three independent studies commissioned by
Eucomed and completed in October?

(1) OJ L 169, 12.7.1993, p. 1.

Answer given by Mr Liikanen on behalf of the Commission

(18 December 2003)

The Commission,
in cooperation with national authorities, has carefully examined the three studies
forwarded by Eucomed. These are, as stated by Eucomed, independent studies that reflect the views of their
authors, and not Eucomed itself.

In discussions with national authorities, an overwhelming majority emphasised that, in their experience,
clinical data for total joint replacement was often lacking and that changes in design were frequently not
sufficiently verified with regards to their long term effects. In their view, risks associated with recovery
surgery should be minimised as much as possible.

As ever increasingly younger patients receive joint replacements, and in the view of National Authorities,
only the strictest conformity assessment procedures should be followed.

Documents presented in the course of discussions do not suggest that stricter conformity assessment
procedures have a negative impact for patients with respect to cost, availability or innovation.

(2004/C 70 E/282)

WRITTEN QUESTION E-3386/03

by Concepció Ferrer (PPE-DE) to the Commission

(17 November 2003)

Subject: Chinese type-approval system (cid:1) non-tariff barrier

A new Chinese product type-approval system for electrical apparatus and components, electromechanical
products, agricultural machinery, tyres and latex products (which affect human life and health, animals,
is
plants, environmental protection and national security, and which currently affects 132 products,
causing alarm within European industry.

The European Chamber of Commerce in China has uncovered 10 or 12 instances of blocked containers,
long-drawn-out procedures and allegations of problems of intellectual property linked with the new
system.

Did the Commission discuss this issue at its last bilateral summit meeting with China? If not, what does the
Commission intend to do to remove this type of non-tariff barrier and guarantee access to the Chinese
market under fair conditions?