My main interest right now is how six designated conformity assessment bodies will be able to surveil a much larger number of IVDs that now need Notified Body involvement.
At the rate Notified Bodies are being designated to IVDR (2 per year since the first designation), we won't have all 17 who applied designated until 2027, and this doesn't constitute any increase in Notified Bodies under IVDR vs. IVDD (18 NBs), though we have gone from 10 - 20% of IVDs needing a Notified Body (IVDD) to near 90% (IVDR).
Even with a progressive roll-out, these numbers seem to make implementation of the IVDR particularly challenging.
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Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States
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Original Message:
Sent: 14-Mar-2022 08:11
From: Gert Bos
Subject: What issues are you looking forward to talking about informally when you meet in person again?
I'm really looking forward to finally meet my regulatory friends live again at Euro Convergence this May.
For me, the unscheduled corridor and diner talks bring out the best in regulatory intelligence as regulatory friends are out there to share their wisdom and exchange views and intuition.
What three topics would you raise when meeting in the corridor or over diner?
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Gert Bos FRAPS, PhD
CTO, Executive Director & Partner at Qserve Group
Baarn
Netherlands
Gert.bos@qservegroup.com
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