Medical Omnibus
INITIATIVEImplementation, Simplification & Better Regulation
The Commission will be ready to propose a targeted legislative package to simplify EU rules for medical devices and in-vitro diagnostics while safeguarding patient safety and public health, including in health emergencies. This follows a targeted evaluation of the MDR/IVDR to address identified bottlenecks and facilitate firms’ operations across the Single Market. Complementary enablers, such as the European Business Wallet, will reduce administrative barriers by enabling secure, verified data and credential sharing for compliance processes. The initiative aligns with the Life Sciences Strategy’s drive to streamline regulation and speed market access for innovation, especially for startups and SMEs.