The European Heart Network (EHN) responded to the European Commission’s open consultation on the proposed revision of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
EHN welcomed the proposal’s objective to accelerate patient access to safe and effective medical devices while reducing unnecessary administrative burden. In its response, EHN highlighted key priorities to ensure the revision delivers for cardiovascular patients, including the need to reflect high-burden diseases in priority regulatory pathways, safeguard the affordability and availability of essential devices, address sex- and age-specific gaps, and strengthen meaningful patient involvement throughout the device lifecycle.