REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025PC1023 The European Commission has finalised translations of its proposals to revise the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), allowing formal discussions to begin in the European Parliament and the Council. These regulations set the rules for how medical devices – including diagnostic tests, implants and digital health tools – are assessed and approved for use in the EU. Policymakers have signalled their intention to move quickly, although no clear timeline for agreement has been set. The Cypriot Presidency has emphasised the need to simplify the regulatory framework while maintaining safety and quality standards. Changes to the IVDR could support the development and availability of specialised diagnostic tests, helping to shorten the diagnostic journey. Revisions to the MDR could also improve access to innovative assistive and therapeutic technologies, and orphan devices.