The EU Regulations 2017/745 (MD Regulation) and 2017/746 (IVD Regulation) establish a new framework for medical and in vitro diagnostic devices, aiming to ensure high health protection and smooth market functioning. Both regulations have extended transition periods (until 2027–2029, depending on risk level) to address implementation challenges and were notified to the WTO. A 2024/25 proposal seeks to streamline the framework by simplifying rules, reducing administrative burdens, improving certification processes, supporting innovation, and enhancing international cooperation while maintaining high safety standards.
EU – Commission Proposal for a Regulation of the European Parliament and of the Council Amending Regulations (EU) 2017/745 and (EU) 2017/746
