Notified body capacity – or a lack thereof – is a topic we love to keep you updated on here at OTP. In our last update on the topic back in April, only weeks before the date of application of the EU Medical Device Regulation (“MDR”), we reported that the 20th Notified Body under the MDR had just been designated, finally meeting a target which the European Union had originally aimed to achieve by the end of 2019.
In that same update, we referred to a presentation from the European Commission indicating that there was a significant pipeline of some thirty-plus Notified Bodies awaiting designation under the MDR. The same presentation referred to a significant pipeline of Notified Bodies awaiting designation under the IVDR, a topic we have touched on separately in the sister piece to this article: IVDR Notified Bodies – here comes the crunch.
Four months on from that update, with COVID-19 restrictions easing and organisations returning to a semblance of working normality, you might expect some significant progress to have been made in working through that pipeline. We understand that the main hurdle to designating Notified Bodies during the pandemic has been the difficulty of conducting on-site audits, a difficulty which should now be falling away. Certainly you might think the MDR date of application having passed on 26 May 2021 would have focused some minds, as conformity assessment under the MDR is now mandatory for all new medical devices which fall within its scope and a number of existing medical devices on the market in the European Union.
We are pleased to report that there has been some progress: there are now 23 Notified Bodies under the MDR. Assuming that this rate of progress is here to stay and we can expect three Notified Bodies to be designated every four months, we should finally have the same level of Notified Body capacity that we had under the predecessor Medical Device Directive sometime in mid-2024.