On 6 October 2025, the BioMed Alliance submitted its response to the European Commission’s call for evidence regarding the targeted revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
While the Alliance welcomes the Commission’s goals to safeguard patient safety and support innovation, it also highlights challenges that must be addressed to ensure continued patient access to safe, effective, and innovative technologies. The Alliance highlights several recommendations, including the neeed to ensure stronger central coordination at the EU level.
