ARTICLE SUMMARY:
The European Commission is embarking on a study this week to formally collect information from national governments, notified bodies, and industry about long-term improvements that could be made to the EU regulations. But don’t look for any reforms to result from the effort until after 2027.
The European Commission is initiating a formal effort this week to collect input on strategies to improve “innovation in governance” of the Medical Device and IVD Regulations. As part of the 18-month, EU-funded study the Commission will engage national authorities, notified bodies, industry, and other stakeholders to investigate where the regulations and their implementation could be better optimized. The outcomes will directly inform a comprehensive evaluation of the MDR and IVDR—and potential recommendations for legislative reforms—that the Commission has promised to deliver by 2027.
