The safety of medical devices such as surgical equipment or implants is to be significantly improved after the adoption of a proposal by the European Commission, today by the European Parliament. There will be stricter rules for the use of potentially toxic materials, for which adequate labelling will be required. Furthermore the safe single use of devices is enhanced.
A study will be done to see how better reprocessing of devices can be achieved. Apart from this, specialized medical software will fall under the scope of the new Medical Device Directives, which have been updated in the light of new technological developments. The European Parliament vote is based on a compromise, reached with the Council, which is expected to adopt the package shortly.
Commenting on the vote, Commission Vice-President Günter Verheugen, responsible for enterprise and industry policy, stated: "This is good news, as today's vote allows for enhanced patient protection and supports medical progress and innovation. It will improve the functioning of the internal market, and strengthen the competitiveness of European industry."Â
Medical devices have become an increasingly important health care sector and have an increased impact on health and health care expenditure. Medical devices encompass some 10,000 types of products, ranging from simple bandages and spectacles, through life sustaining implantable devices, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment. The public expects that such medical devices meet the highest safety standards.
The new legislation will clarify essential elements for safety of medical devices such as clinical evaluation and conformity assessment, as well as bringing new, positive, provisions such as those aimed at increasing transparency. - European Union
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