Last week EU Commission has announced EU MDR 2017/745 designation of Eurofins Expert Services Oylocated in Finland as the 20th notified body (NB). But considering the current the performance of these for accepting applications, question “Have we enough Medical Device Notified Bodies for EU Market?” remains open.
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, it seems that this additional year will be not enough.
With less than 2 months to the new DoA, the representatives of the sector have serious concerns as to whether the number will be sufficient for the implementation.
The first concern is that the COVID 19 pandemic is still alive. Although the comission allowed the remote initial certification audits in certain cases, capacity of the current NB’s seem not to be sufficient for the sector.
The second fact is that although the number of designated medical device notified bodies is 20, 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.
If the rate of designation of NB’s continues at this pace, most probably the sector will face the same problems experienced at the end of 2019 and the additional year of DoA will have no added value.
A list of notified bodies authorized by the Commission is available on the nando website.