October 9, 2023
The RAPS Convergence 2023 conference concluded on 5 October 2023. For a few glorious days, professionals convened in Montreal, Canada to discuss all aspects regulatory. Emergo by UL consultants attended and presented at the conference, and are providing reports on key themes and topics discussed and debated during the event.
Background: Notified bodies and MDR compliance
One topic discussed extensively covered notified bodies and the European Medical Devices Regulation (2017/745, MDR). Notified bodies have been working to harmonize their activities. Notified body representatives have attended meetings and as one example of successful collaboration, published Team-NB Best Practice guidance documents on the MDR (and In Vitro Diagnostic Devices Regulation (2017/746, IVDR).
Themes on notified bodies
The following themes were discussed:
- There is a lot of data collected on notified bodies.
- The 26 May 2024 deadline is rapidly approaching.
- Structured dialogues.
Data on notified bodies
There is data being collected on notified bodies. The MDR Article 121, evaluation, expects the European Commission (EC) to assess the performance of the MDR. The EC has commissioned a “Study on Regulatory Governance and Innovation in the field of Medical Devices" and the first stakeholder meeting was organized in September.
In addition, the EC published a survey on notified bodies in July 2023 with data through the end of March. However, notified body representatives lamented that they have been continuing to provide data to the EC, but these updates have yet to be released.
MDR and the 26 May 2024 deadline
The deadline of 26 May 2024 from Regulation 2023/607 is rapidly approaching for manufacturers to have submitted an application for a MDR certificate in order to continue to market legacy devices. All notified body representatives at RAPS shared that notified bodies have capacity and can accept applications for review.
In addition, while the MDR is prescriptive in the application process (Annex VII, Section 4.2 NB quotations and pre-application activities, Section 4.3 application review and contract), there are differences in the application process with the different notified bodies.
It is recommended that manufacturers do not delay and engage their identified MDR designated notified body, or discuss with potential MDR designated notified bodies now the application process. Some notified bodies have guidance on the process.
Structured dialogues between manufacturers and notified bodies
The guidance MDCG 2022-14, item 15, encouraged the use of structured dialogues between manufactures and notified bodies. While notified bodies are unable to consult, the MDCG encourages this to facilitate the progress of the notified body review. This was discussed many times during RAPS, as in reality has not occurred since publication of the guidance in August 2022. The current understanding is that there would be more intelligence forthcoming related to structured dialogues.
It was presented that notified bodies who are aware of their manufacturers who use Article 54(1), have become involved in these expert panel clinical evaluation consultation procedures (CECP).
There are initiatives expected to improve the conformity assessment process with the notified body. The EC is actively monitoring the EU regulatory enterprise.
Notified body and industry representatives remain optimistic. Now is the time to engage your notified body designated to the MDR, as the first deadline is less than eight months away.
The enterprise is working towards compliance to the MDR, though manufacturers have to keep making forward progress.
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