EU Launches Public Consultation on Medical Devices and In Vitro Diagnostics Regulations

The EU medical device and IVD regulations are undergoing a comprehensive evaluation through the European Commission public consultation, open until March 21, 2025. This initiative aims to assess the effectiveness of the current medical device regulatory framework in ensuring safety and innovation while addressing key challenges faced by SMEs and fostering improved market access. Stakeholders are encouraged to share insights on critical issues, such as the availability of orphan devices, the impact of IVD regulations, and the need for streamlined processes to support a competitive and evolving healthcare innovation landscape in the EU.