Proposal for a Regulation of the European Parliament and of the Council on Medical Devices and Amending Directive 2001/83/EC
On behalf of its member companies, the Association of Medical Device Reprocessors (AMDR),1 applauds the European Council’s efforts regarding its Medical Device Regulation proposal (“Council’s Proposal”). Overall, AMDR strongly supports a number of measures in the Proposal. Significantly, the Council secures a regulatory pathway for firms to market reprocessed/remanufactured “single-use” devices (SUDs) by demonstrating that their products meet manufacturer requirements. This will allow hospitals and providers in the EU the ability to provide safe and effective reprocessed SUDs at less cost, while benefiting the environment. We, however, request that Trialogue negotiators strongly consider several necessary revisions to Article 15 and 49 to ensure clarity and fairness in the final Regulation.
AMDR’s suggested considerations and revisions are available in the full position paper here.