We all knew the EU-MDR transition period would be a tough time for the whole medical device system. We all knew it would be tougher for Notified Bodies dealing with a hugely increased workload; we all knew it would be tougher for competent authorities charged with extra responsibility and requirements to apply extra scrutiny; we all knew it would be tougher for manufacturers required to comply to much stricter requirements with limited guidance and insufficient Notified Body capacity. But now Notified Bodies are taking the “crisis” to the next level presenting a situation that might be even worse than we thought or feared…
The MedTech industry has been crying out for a more pragmatic approach to the transition for a long time, but now also Notified Bodies are raising the alarm. As that is more unusual it also is, if you want, more concerning.
Team-NB, the trade association representing 26 leading Notified Bodies, has recently published a position paper asking for some solutions to be discussed between regulators and EU Commission to avoid bringing the system to a halt and to ensure devices continue to be available for patients. This document presents the results of a survey conducted by the EU Commission regarding the number of certificates expiring between now and May 2024, the final date of the transition regime in which old MDD and AIMD certificates can serve as basis to keep legacy products on the EU market.
All 54 Medical Devices Notified Bodies were asked to provide information but only 34 actively responded. Which is already slightly concerning because it makes you wonder what happened with the other 20: are they planning to discontinue the business and therefore they are not interested? are they already overwhelmed and therefore not able to dedicate some time to this survey? are they unable to pull out the data from their systems? are they simply uninterested in what is going to happen in the next 4 years? Whichever option you choose, it is concerning.
The survey results show a rising number of certificates expiring in the course of the next 4 years. In total just over 13,000 certificates are due to expire, which is a problem in itself, but the situation is even more critical when you consider that more than half of those (7,272) are due to expire in 2024. And don’t forget in 2024 the soft transition period comes to an end in May , so 2024 cannot be considered a full year.
The Team-NB’s Notified Bodies are seriously concerned about this peak. And not only about that, as this peak must be considered together with the increased requirements and duration of the conformity assessments, with the extra-activities brought in by the MDR (e.g. routine review of updated PSURs and SSCPs), with the significant effort most Notified Bodies will have to put into their re-designation around 2023-2024 and, not last, with the additional challenges due to the current pandemic.
What is the risk if this situation is not addressed? The Notified Bodies are very straightforward on this and state that the risk is the “shortages of medical devices in 2024 which could lead to risks for patients”. It is not common for Notified Bodies to use this blunt and direct language, so it gives you an idea of the scale of the problem.
The position paper suggests two possible actions to try and mitigate this risk. The first is very practical: Notified Bodies are asking more freedom to conduct audits remotely. Conducting (and receiving) audits during the COVID-19 crisis has been challenging, but Commission and member states have shown only some flexibility in allowing remote MDD audits. The same flexibility has not been yet put on the table for initial and surveillance MDR audits. There is a lot of pressure in this direction but, so far, no concrete step.
The second suggested action seems a little vaguer. Notified Bodies suggest encouraging manufacturers to spread their MDR submissions between now and 2024 and not leave them all for the last year. That would certainly reduce the peak in 2024 but it makes you wonder: 1) how can you practically encourage manufacturers to do that? Especially considering they are already trying to spread their submission over a certain period of time to avoid being overwhelmed themselves; and 2) would levelling the peak be really enough? Would the designated NB be able to handle 13,000 submissions in less than 4 years, even if evenly spread?
So, the positive side of this story is the willingness of Notified Bodies to be open, clear and pro-active on this matter. They have added their worried voice to that of MedTech Europe and the whole industry. Now let’s hope that Commission and member state listen to this cry for help and at least start an open discussion with the involved parties.
Meanwhile, if you need any support to try and submit your dossiers to your notified body earlier, our team is available and ready to connect.