Article
How Will The EU Parliament Shape The MDR/IVDR Revision? Draft Report Indicates How Parliament May Seek To Amend Commission’s Proposals
The European Parliament's draft report proposes over 130 amendments to the Commission's plan for overhauling medical device regulations, introducing new categories like "niche" devices while expanding coordination mechanisms between EU authorities. These changes aim to balance regulatory simplification with patient safety, potentially reshaping how medical devices and in vitro diagnostics are classified, assessed, and brought to market across the European Union.
Arnold & Porter