On September 26, the European Commission released its comprehensive proposal for a European-wide Medical Device Regulation. Article 15 of that proposal outlines a proposed regulatory framework for the reprocessing of so-called “single-use” medical devices. AMDR welcomes the Proposal and the Commission’s commitment to setting clear regulatory rules for reprocessing. America’s third-party medical device reprocessing companies are confident that Europe, like the United States, will adopt a strong framework that will allow only safe, regulated reprocessing to continue in Europe — thus allowing European hospitals to reduce their medical device costs and the needless generation of medical waste.
Whereas AMDR strongly supports a number of proposed measures laid out in the Commission’s Proposal, a number of points would require improvement during the legislative procedure of the European Parliament and the Council of Ministers in order to clarify the Regulation and further enhance safety and quality of reprocessed products.
For a full outline of AMDR’s reaction, CLICK HERE