On 8th of August 2020 EU Commission has announced EU MDR 2017/745 designation of DQS Medizinprodukte GmbH as the 16th notified body (NB). But the question “Have we enough Medical Device Notified Bodies for EU Market?” remains open.
Since beginning of 2019, when BSI Assurance UK Ltd (0086) has been designated as the first NB 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 9 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 due to the COVID 19 pandemic. Medical device notified bodies still cannot perform most of the onsite audits. The remote audit tools are used mainly for continuing assessment visits in line with the commission guidance.
The second fact is that although the number of designated medical device notified bodies is 16, (15 if we exclude BSI UK due to Brexit), 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.