The RAPS Convergence 2023 concluded on 5 October 2023. For a few glorious days, professionals convened in Montreal, Canada to discuss all aspects regulatory.
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]
- There is a lot of data collected on notified bodies
- The 26 May 2024 deadline is rapidly approaching
- Structured dialogues
[Concluding remarks]
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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RAPS Convergence 2023: The Status of European Notified Bodies | Emergo by UL
RAPS Convergence 2023: The Status of European Notified Bodies
Emergo by UL reports from the latest Regulatory Affairs Professionals Society (RAPS) medical device regulatory and quality affairs conference in Canada.
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