We have previously written at length about the continuing regulatory bottlenecks caused by the low numbers of notified bodies for the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
A new set of slides from the European Commission sheds some light on where all the notified bodies have gone.
The good news is that we do have 24 notified bodies for MDR. However, 29 applications for designation under MDR remain in progress. Of these, two notified bodies will be designated imminently (which should bring us to 26 by Christmas 2022). However, ten applicants haven’t even received preliminary assessment reports, especially when considering the relative speed and ease of this initial stage.
Some 18 months after the original date of application of the MDR (May 2020), it is disconcerting that this bottleneck remains and is not going to be resolved in the near future.
The situation is similar under the IVDR, prompting the EC to take action to alleviate what they called a “grave shortage” in notified body capacity. With just over six months to go before the date of application, only six notified bodies have been designated and only 17 applications have been received (and four of them have yet to even receive a PAR).
The IVDR poses significant challenges given the up-classification of virtually all products within its scope.
The sector can do little more than cross its fingers and hope that the pending applications proceed more quickly through the process.