The outlook Team NB published on its website the number of certificates expiring over the transition period from the MDD to the MDR.
These numbers are based on a survey conducted from August until 25 of September. 34 of the 54 notified bodies responded. Here is the table published by TEAM NB:
From: Position paper Directives expiring certificates – impacts and suggested solutions dated 2020 12 15 (https://www.team-nb.org/wp-content/uploads/2020/12/Team-NB-PositionPaper-ExpiringCertificates-20201215.pdf)
These numbers are stunning and of a high concern. The solutions proposed are simple:
- Remote audits
- Encouraging the manufacturers to get certified earlier
Are these proposed solutions enough?
On 18 December 2020 TUV Sued published that they have certified 100 manufacturers under the MDR and IVDR. See the publication here.
TUV Sued was notified under the MDR in May 2019, and the first cert was issued in September 2019. Then it was notified under the IVDR in June 2020 and issued the first IVDR cert in October 2020.
100 MDR Certificates in appr. 1.5 years. We have to ask again: Are the proposed solutions enough?
Here are the factors not shown in the figures:
1. Only 34 NB responded. So, there are certainly more certificates!
2. Manufacturers still try to certify MDD products until May 2021 and do not focus yet on the MDR!
3. A number of new certificates will have to be issued on products never certified before (MDD risk class I – higher risk class under the MDR and the reusable surgical instruments). A good number of manufacturers engage with a notified body for the very first time.
Keeping everything in mind:
The answer to the solution proposed by TEAM NB is: IT MAY NOT BE ENOUGH!
What may be a strategy?
Now is the time to apply with your NB. The first tests have been done by the NBs who have been MDR notified, and they should be ready to take on the new MDR business. Resources may not be in place in 2023 and 2024 to manage the peak for manufactures in due time. Therefore:
Just focus on one product group, or even just one product, and apply! This will get your QMS reviewed and also should get you faster feedback on any deficiencies in terms of your technical file. The big advantage is that you know what to expect from the NB for the remaining technical documentations.
With careful planning you may then get all the products covered by the next surveillance of the MDR.
It is important to know that the devices may be covered by the two certificates (MDD and MDR) at the same time. You do not have to “upgrade” all products to the MDR world at the same time. As long your MDD cert is valid, the remaining devices may be marketed under the MDD until expiration of that cert and at the latest until 2024. And certainly, the devices covered by the MDR do not need to have an immediate update in terms of the labeling since they indeed stay valid with the MDD. Involve your notified body concerning this approach.