A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus.
The European Commission published a survey of data from notified bodies (NB) conducted by the Austrian National Public Health Institute (Gesundheit Österreich GmbH), and research groups Areté and Civic Consulting on 25 July. The survey provides an overview of the MDR/IVDR transition process as of the end of March 2023. The results show that compared to October 2022, the number of MDR/IVDR applications and certificates has increased significantly.
Between 22 October 2022 and 31 March 2023, the number of MDR applications rose more than 40% from 8,120 to 11,418. The number of MDR certificates also rose almost 50% during that time from 1,990 to 2951…
