A recent survey shows progress in the number of applications being filed with notified bodies (NB) and certificates issued under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). However, there continues to be issues with applications that result in refusals from the NBs.
On 30 October, the European Commission released results of its tenth survey of NBs and how they have processed certifications and applications to transition products to the MDR and IVDR. It was conducted between January and June 2024 and provides a snapshot of the current medtech regulatory landscape.
Compared to June 2023, when NBs reported they had received 13,177 MDR applications and issued 3,899 certificates, the number of MDR applications a year later went up to 26,185 and NBs issued 8,905 certificates. The survey also broke down the kinds of MDR applications…
