WRITTEN QUESTION P-1622/00 by Karin Riis-Jørgensen (ELDR) to the Commission. Error in authorising medical device.
Date: 2000-05-16
Institutions: European Parliament, Provisional data
Subjects: Community certification, competence of the Member States, drugs classification, market approval, medical device

13.2.2001

EN

Official Journal of the European Communities

C 46 E/207

(2001/C 46 E/248)

WRITTEN QUESTION E-1613/00

by Cristiana Muscardini (UEN) to the Commission

Subject: Unstable situation of AT3 staff at the JRC in Ispra

(29 May 2000)

Temporary staff on three-year contracts with the JRC in Ispra have organised a trade union campaign
designed to persuade the Centre(cid:146)s management to renew their contracts. The JRC(cid:146)s new policy for research
staff provides for flexibility in the management of short-term projects and staff on three-year contracts
account for 25 % of total staff and may not be re-employed on expiry of their contracts, but are replaced
by new staff instead.

1.

Is this constant three-year turnover of staff a rational policy?

2.
Surely the failure to renew the contracts of staff who have proved to be excellent during their term
of employment, replacing them with new staff who do not have the work experience acquired by AT3
staff, represents a senseless waste of resources?

Is it one of the objectives of the new research staff policy to introduce permanent instability for

3.
employees?

4. Would it not be more appropriate, in the interests of research and of the Centre carrying it out, to
devise new selection procedures instead of the automatic turnover system, so as on the one hand to ensure
continuity in research activities, especially in the case of single projects, and, on the other, end the system
where staff are automatically replaced at the end of their contracts?

5. What are the Commission(cid:146)s views on this matter?

Answer given by Mr Busquin on behalf of the Commission

(10 July 2000)

The Honourable Member is referred to the Commission(cid:146)s answers to Written Questions P-0692/00 from
Mr Speroni (1) and P-1734/00 from Mr Di Pietro (2).

(1) OJ C 330 E, 21.11.2000, p. 206.
(2) See page 212.

(2001/C 46 E/249)

WRITTEN QUESTION P-1622/00

by Karin Riis-Jłrgensen (ELDR) to the Commission

(16 May 2000)

Subject: Error in authorising medical device

There are two manufacturers on the world market of products which enable cancer patients undergoing
chemotherapy to retain their hair, these being the Danish-Swedish firm Dignitana and the UK(cid:146)s Paxman.

Permission to sell medical equipment within the EU is subject to a special authorisation procedure. The
higher the health risk, the more stringent the criteria for tests, documentation and safety measures.

Paxman(cid:146)s product is registered in the lowest class 1, whereas Dignitana(cid:146)s product is registered in class 2a.
This means that there are significantly fewer criteria for the authorisation of Paxman(cid:146)s product. The UK(cid:146)s
Medical Devices Agency has acknowledged that Paxman(cid:146)s product has been wrongly classified but Paxman
has, nevertheless, been able to continue producing and selling its product in the EU.

C 46 E/208

Official Journal of the European Communities

EN

13.2.2001

is the Commission(cid:146)s position on the erroneous classification of medical products? Does the
What
Commission consider that erroneous classification of medical products causes distortion of competition?
Should identical products not be placed in the same class? Which consideration weighed more heavily in
the balance (cid:129) the free movement of goods or patient safety? Does the Commission believe that the
wrongly classified product should be withdrawn from the market until
it has undergone a correct
authorisation procedure?

Answer given by Mr Liikanen on behalf of the Commission

(16 June 2000)

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (1) provides criteria for the
classification of medical devices, which have been developed so as to ensure a high level of health
protection. However, difficulties of
the
importance of a correct classification of devices to ensure safety, loyal competition and free movement of
goods. Various mechanisms exist to solve problems of classification.

interpretation do arise. The Commission is fully aware of

In case of a dispute between the manufacturer and the notified body, the matter will be referred to the
national authority. In addition, guidelines for classification have been agreed between the Commission,
Member States(cid:146) authorities, notified bodies, the industry and other interested parties. These are updated
whenever necessary. Notified bodies meet on a regular basis and discuss questions of classification.
Furthermore, the Commission organises on a regular basis classification meetings with all
interested
parties, where common approaches on specific devices are consensually defined. As regards devices that
nevertheless have been wrongly classified, the Directive foresees that Member States will oblige the
manufacturer (or his representative) to correct the classification (including conformity assessment proce-
dures and labelling) or, otherwise, to restrict, prohibit the device and to withdraw it from the market.

With reference to the particular case raised by the Honourable Member, a manufacturer who considers
that he suffers from a erroneous classification, should address a request for intervention to the national
authority.

(1) OJ L 169, 12.7.1993.

(2001/C 46 E/250)

WRITTEN QUESTION P-1623/00

by Roberto Bigliardo (TDI) to the Commission

(16 May 2000)

Subject: Workforce of Tonno Nostromo in Vibo Valentia

Is the Commission aware of the threat to jobs at the Porto Salvo factory of Tonno Nostromo (Calvo
Group), a company which for years has been involved in, and has accounted for, a substantial market
share in a region with very high unemployment, and which is now claiming that the returns on processing
the same product are higher in Spain than in Italy.

In particular, Tonno Nostromo(cid:146)s workers have drawn up a conversion plan for setting up a tuna canning
centre in Calabria, while the trade unions have stated that they are willing to discuss the flexibility and
equipment needed to organise such work more efficiently.

Will the Commission state whether it is considering intervening to help speed up this industrial conversion
process?