The urgent need to revise the Medical Devices Regulation

In this non-legislative resolution, Parliament addresses the urgent need to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The text notes that despite their aim of strengthening safety, transparency and clinical performance, implementation of these regulations has created significant challenges, including certification delays, shortages of devices, difficulties for small and medium-sized enterprises, unpredictable timelines due to a lack of harmonised procedures across notified bodies, and repeated extensions of transitional periods to prevent devices being withdrawn from the market. It highlights concerns about disparities in access across Member States, obstacles to innovative and substance-based devices, and the certification status of e-health applications. Parliament calls on the Commission to propose delegated and implementing acts to the MDR and IVDR.