Team Notified Body (NB) released two updates in the past week:

1. Position Paper on New MDR Transition Timelines and NB Capacity
2. Transfer Agreement for Legacy Devices

Position Paper: New MDR Transition Timelines & NB Capacity

The paper gives a good overview of the current situation. As most know, the MDR implementation has been beset with delays – not only the start date of the MDR itself, but also EUDAMED, guidance documents, common specifications, lack of harmonized standards, long timeframes to designate new Notified Bodies and/or process scope expansion requests, and more.

Further, the paper itemizes very real concerns by the Notified Bodies, even with the newly extended timeframe. For example, once the news about the MDR extension period was released:

• • The rate of new applications dropped, and
  • Response time for manufacturers undergoing MDR certification increased, e.g., taking longer to address non-conformities and complete the certification process

What is the big deal? More time has been granted, right?

The issue is that by the end of 2022, only 14% of MDD/AIMDD CE Certificates have been transitioned to the MDR. That leaves 86% of medical devices that still must be transitioned. More, in fact, since the MDR up-classed many devices that were previously “self-certified”. It also now regulates products previously regulated as non-medical devices, such as cosmetic lasers and colored contact lenses.

The extension has created a (false) sense of security, and has led some manufacturers to ‘ease the gas’ on their MDR transition activities. As a result, the Notified Bodies are again facing a bottleneck at the upcoming deadlines:

• • 26 May 2024 for legacy devices to have lodged an application with a Notified Body
  • 26 September 2024 for the written agreement to be in place

If a manufacturer has an MDD/AIMDD legacy device and waits until Q2 of next year, they put themselves in the very real position of fighting for Notified Body attention.

Essentially, the NBs are saying: Right now, we have more room to accept your business. Please do not delay your application and create an unmanageable bottleneck next year.

And in between the lines: if you do so, you put your own certification at risk.

Transfer Agreement for Legacy Devices

A manufacturer may decide to switch to a different Notified Body to MDR CE Mark their device, separate from the one that issued the MDD/AIMDD CE Certificate. When this occurs, the manufacturer may request that the new Notified Body take over the surveillance activities for the legacy device. If both Notified Bodies agree, then an agreement must be put into place.

The transfer agreement should be signed by the manufacturer (“Certificate Holder”), the Incoming NB, and the Outgoing NB.

Team NB has drafted a template agreement that can be used for this purpose. It includes terms such as:

• • Certificate Holder shall continue to apply the Outgoing NB’s 4-digit identification number for legacy devices, unless otherwise agreed to in the Agreement
  • Outgoing NB may disclose information related to the assessment and certification of the legacy devices to Incoming NB, to enable direct communication between Outgoing and Incoming NB
  • Incoming NB shall assume full responsibility for NB surveillance activities for legacy devices, including continued conformity assessment activities, monitoring and assessment of Certificate Holder’s vigilance system, communication with competent authorities regarding the legacy device, and more