Proposal for a Regulation of the European Parliament and of the Council of the on Medical
Devices and Amending Directive 2001/83/EC


On behalf of its member companies, the Association of Medical Device Reprocessors (AMDR),
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 available in the full position paper at link.