The Number of Medical Device Notified Bodies is increasing

EU Commission has announced EU MDR 2017/745 designation of 42th notified body (NB). The number of Notified Bodies is expected to increase with the issue of the amendment for MDR extension on 20 March 2023 .With increasing number of NBs manufacturers may find more options to certify their devices.

Since beginning of 2019, when the first NB has been designated for EU MDR 2017/745 there have been huge discussions for the availability of NBs for the medical device industry. The problems brought by the COVID 19 pandemic increased the uncertainties. Although the commission made the historical decision to postpone the date of application (DoA) to 26 May 2021, the additional year did not bring the needed capacity.

Still with 42 NBs, the representatives of the sector have serious concerns as to whether the number will be sufficient for the implementation.After the official announcement of the exension proposal which is mentioned in the first paragraph, it is expected that this number will be increased.

The fact is that although the number of designated NB is 42, not all of them have been designated for the full scope. Therefore, many manufacturers with specific type of medical device, cannot get reasonable quotations for MDR transition. The situation for manufacturers like start-ups looking for initial certification and the ones located outside EU is even worse. Naturally with limited resources the NB’s are trying to plan the transition for their existing clients.

A list of notified bodies authorized by the Commission is available on the nando website.