Brussels, 30/03/2007 (Agence Europe) - On Thursday 29 March, the European Parliament approved the compromise reached with the Council on the revision of three directives on medical devices. This text, which will become definitive after its official approval by the Council, provides, amongst other things, for stricter labelling rules for potentially dangerous materials. The scope of application of the regulation has been extended to take account of the evolution of new technologies.
Commenting on the vote, Günter Verheugen, Vice-President of the Commission with responsibility for Enterprise and Industry, said “this is good news, because today's vote opens up the way for greater patient protection and promotes progress and innovation in medicine. It will improve the functioning of the internal market and increase the degree of competitiveness of European industry".
Medical devices are becoming an increasingly important sector within healthcare and have an increased impact on health and health care expenditure. They cover some 10,000 types of product, from simple bandages and glasses to the most sophisticated equipment, to be used in diagnostic medical imagery and minimally invasive surgery, via implantable devices to extend life expectancy, the Commission points out in a press release. The new legislation will clarify essential elements for the safety of medical devices, such as clinical evaluation and controls on conformity, which will also bring in new positive provisions, designed to increase transparency, amongst other things. The revision provides for the following: - in order to clarify the situation in terms of reprocessing medical devices, the definition of the notion of “single usage” and the corresponding labelling will be made uniform within the EU; - manufacturers must avoid the use of carcinogenic and mutagenic substances, and substances harmful to reproduction (CMR) in medical devices; - devices which may release phthalates in the organism of the patient must be labelled.
It is worth noting that the issue of “combined products”, meaning medical devices combined with cells or tissues of human origin, was not raised. This will be dealt with by other legislative proposals which are being prepared at the moment, such as the regulation on innovative therapies. (oj)