The European Union (EU) has published regulations in the Official Gazette to ensure full compliance with current medical device legislation, amending the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation. Changes have been made to reduce the risk of medical devices being unavailable for supply, including the extension of the transition period for the MDR until May 26, 2026, December 31, 2027, or December 31, 2028, depending on the risk class determined by the MDR classification rules for certain manufacturers who meet the necessary approvals.