European Commission’s Proposal to Amend the MDR and IVDR

The European Commission has published the long-awaited proposal amending Regulations (EU) 2017/745 (the “MDR”) and (EU) 2017/746 (the “IVDR”) as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices. This initiative responds to widespread concerns from the industry and Member States that the current framework has become overly complex, costly, and unpredictable for manufacturers. The proposal aims to preserve the high level of patient…
By: Hogan Lovells