Medical devices amendments ‘creates confusion’

Date: 11/12/03

A LITTLE-NOTICED amendment to a review of EU pharmaceuticals' legislation facing a plenary vote in the European Parliament on 17 December has seriously irked Eucomed, the European Medical Technology Industry Association.

Its Director-General, Maurice Wagner, claims the amendment on 'borderline products' - medical devices such as drug-coated stents (tubes made of metal or plastic inserted into vessels or passages to keep them open) - "creates confusion" where it should not. "These are not pharmaceuticals," he said. "A pharmaceutical enters the body, is metabolized by the body and is excreted by the body." Backed by the European Commission and introduced by French conservative MEP Françoise Grossetête, rapporteur for two directives in the 'pharma' package, it was thrown out in a first reading at a November environment committee vote, but has since been reintroduced by Grossetête.

EUCOMED, the European Medical Technology Industry Association, claims that an amendment to an undergoing review of pharmaceutical legislation has caused confusion. The amendment concerns 'borderline products' ie medical devices, which EUCOMED argues are not pharmaceutical items. The European Parliament is due to vote on the proposed legislation on 17 December 2003.

http://www.eucomed.be/ http://www.eucomed.be/

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