Brussels, 05/10/2006 (Agence Europe) - The Committee on the Environment, Health and Consumer Protection at the European Parliament adopted by unanimity less one vote, on Wednesday 4 October, a report by German Christian Democrat Thomas Ulmer, largely approving the European Commission's proposal on revision of the directives on medical devices. Some amendments aimed at strengthening the text were adopted. They will be examined during a forthcoming plenary session at first reading on this proposal under codecision procedure.
The amendments above all propose clarification of a legal kind: precision of definitions (for example, as far as software is concerned, only those intended for diagnosis or therapy may be recognised as medical devices under the directive), better delimitation of the scope of the directives to avoid overlapping with other similar directives (cosmetics, advanced medicines and therapies), and an additional annex specifying the products covered and their classification. With a view to strengthening the measures intended to ensure patient safety and that of healthcare workers, the members of the committee wish to fix European standards for the reprocessing of medical devices, especially when this concerns material conceived for single use. They also consider that all imported provisions should respect Community standards, and that the sale of material on the Internet should be supervised to ensure such products are not a threat to consumer health. MEPs stress, moreover, that the European Commission must ensure the correct functioning of the early warning system if a fault is detected in a product in any Member State and call on the Commission to assess the functioning of the data bank foreseen by the directive, twelve months after its entry into effect. Finally, manufacturers should, they say, be involved in decisions relating to the classification of their products. (oj)