Do the math:
- Regulation 2023/607 amending the MDR appears to give extra time, but that is a dangerous misunderstanding
- This Regulation gives notified bodies extra time, but manufacturers have only one year left to be ready
- Between 1 June 2023 and 26 May 2024 over 1,000 new notified body applications must be successfully processed
- Until now only 300 applications have been processed per month
- Do the math. It will be busy in May next year… very busy…
The MDR was created under the assumption that manufacturers would be able to switch from the AIMDD and MDD to the MDR during their normal certification cycle. However, it took years before the first notified body was designated and the designation process is still ongoing, supporting structures, like EUDAMED, expert panels, reference labs, implementing acts, guidance documents, etc., were late, or still have not materialized, and external factors, like Brexit and COVID, depleted capacity from already stretched staff. As a result, many devices are not certified and it is unlikely they will become certified by May 2024. In order to keep devices on the market, Regulation 2023/607 allows for later certification of certain groups of devices; the so-called ‘legacy devices’.
A very important criterion to qualify as a legacy device is that there must be an application for MDR certification filed at a notified body by 26 May 2024 and an agreement for certification and surveillance signed by that notified body by 26 September 2024.
This tip of the week demonstrates that manufacturers that have not yet filed an application must act NOW. The statistics do not favor companies that think they can wait.
Notified bodies survey
On 24 October 2022, the European Commission published a survey among notified bodies about their certification situation. This survey showed the following chart:
The numbers in this chart are accumulated. You can see there were just over 8,000 applications in total by October 2022. Assuming these numbers were taken on the first of every month, it is possible to calculate the average number of applications per month. The number is quite stable: about 300 per month (298, to be exact). Extrapolating this to 1 June 2023, there would be about 10,500 applications for certification by now. But what does that number mean…?
In the same survey, it says that there were about 23,000 MDD and AIMDD certificates issued. Some companies may decide to leave the market and devices may be withdrawn. At the same time, quite some devices have been up-classified requiring a certificate from a notified body for the first time. Assuming that amount of 23,000 certificates is still valid, and there are now 10,500 applications filed, there are still 12,500 applications to be processed. Divided by 12, this would imply just over 1,000 applications per month.
Another notified body crunch…?
The capacity to process applications by notified bodies needs to increase from just under 300 to over 1,000 per month. This sounds ambitious. And please do understand that any application that is not processed now, may be the application that does not make it by 26 May 2024.
If you don’t have this application filed, I recommend you start with that now. The good news is that most consultants have a ‘low season’ in July and August, so you can make use of that. The bad news is, that if their capacity gets stretched, they may start working with seriously inflated expedited fees or not even pick up their phone. This may start as early as December of this year.
If you want to find a suitable notified body and prepare for the application, reach out: