WRITTEN QUESTION E-1749/02 by Ian Paisley (NI) to the Commission. Criteria for evaluating medical devices.
Date: 2002-06-19
Institutions: European Parliament, Provisional data
Subjects: United States, approval, bio-ethics, experiment on humans, market access, medical device, medical research

5.12.2002

EN

Official Journal of the European Communities

C 301 E/221

(cid:1) As an exception from the main rule of reserving posts of captains and first officers to Spaniards,
Article 8(3) of the Royal decree opens up the posts of captain and first officer, under conditions of
reciprocity, to the nationals of other Member States as regards employment on merchant ships with a
gross tonnage of less than 100 gross tonnage (GT), which carry cargo or fewer than 100 passengers
and operate exclusively between ports or points situated in areas in which Spain has sovereignty,
sovereign rights or jurisdiction.

(1) Reference for a preliminary ruling by the Schleswig-Holsteinisches Oberverwaltungsgericht in the administrative-law
case of 1. Albert Anker, 2. Klaas Ras, and 3. Albertus Snoek against Federal Republic of Germany, Case C-47/02, OJ
C 109, 4.5.2002.

(2002/C 301 E/233)

WRITTEN QUESTION E-1749/02

by Ian Paisley (NI) to the Commission

(19 June 2002)

Subject: Criteria for evaluating medical devices

1. What are the criteria used in evaluating artificial medical devices (i.e. heart valves) manufactured in
the USA or outside the EU for use within the EU?

2. Why should these devices be used in the EU prior to approval in the USA, or country of origin/
manufacture?

3. What analysis/testing was done in the case of the ‘St. Jude,’Masters‘Series, silzone-coated artificial
mechanical valve prosthesis’ prior to approval for use in the EU?

4. Why was this device accepted and approved in Europe for over a year before approval by the Food
and Drug Administration (FDA) in the USA?

5.
Considering that EU citizens are not in a position to file for punitive damages, what steps can be
taken to ensure that these citizens are not being used as human ‘guinea pigs’ in an effort to provide a
cheap testing ground for these ‘prototypes’?

Answer given by Mr Liikanen on behalf of the Commission

(15 July 2002)

Medical devices intended to be placed on the Community market imported from a third country must
meet the same requirements as devices manufactured in the Community for the Community market. These
are laid down in Council Directive 93/42/EEC of 14 June 1993 on medical devices (1) (hereafter ‘Medical
Devices Directive’), and relate to substance and conformity assessment.

Access to the European market does not depend on approval in the United States based on American
requirements. It is the manufacturer who decides where he wants to sell his product first, and who
consequently has to ensure that his products meet all regulatory requirements applicable in the relevant
market.

The Commission expects that all analyses and tests were carried out that are applicable to heart valves
under the Medical Devices Directive. It is the task of Member States to ensure that products placed on the
market effectively conform to the relevant requirements laid down by this Directive.

(1) OJ L 169, 12.7.1993.