Anyone had an MDR technical file review/audit yet?
- Thread starter Watchcat
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Thanks for the reply. I am mostly interested in timeframes:
- From application to tech file review/acceptance.
- From tech file review/acceptance to audit.
- From audit to certificate.
Device class might be interesting to know, too.
Would also be interested to know which NB, but if you are not comfortable sharing that information, perhaps whether it is (BSI/TUV) versus one of the NBs that was designated in the last few months?
As for anything more substantive about the review, it is hard to know what to ask. Everyone has been struggling with many issues, due to having only the language of the MDR as their guide, few guidances to clarify/expand on the meaning of the language, and, sometimes, no guidance from their overwhelmed NB, either. So I guess I will just add that, if you found anything about the experience especially enlightening and that you would be comfortable sharing, that would be good to know too.
- From application to tech file review/acceptance.
- From tech file review/acceptance to audit.
- From audit to certificate.
Device class might be interesting to know, too.
Would also be interested to know which NB, but if you are not comfortable sharing that information, perhaps whether it is (BSI/TUV) versus one of the NBs that was designated in the last few months?
As for anything more substantive about the review, it is hard to know what to ask. Everyone has been struggling with many issues, due to having only the language of the MDR as their guide, few guidances to clarify/expand on the meaning of the language, and, sometimes, no guidance from their overwhelmed NB, either. So I guess I will just add that, if you found anything about the experience especially enlightening and that you would be comfortable sharing, that would be good to know too.
Our Audit was last year in December. Unfortunately we are still waiting for our certificate. We are manufacturer of class IIa medical devices in Germany.
The Tech file review lasted about 3 month. Our NB is TUV.
I recommend an intensive exchange with the notified body and the responsible auditor. This helped us a lot!
Important topics are:
-Vigilance
-Post Market Surveillance: PMS, PSUR, PMCF
-UDI, MDRLabeling
The Tech file review lasted about 3 month. Our NB is TUV.
I recommend an intensive exchange with the notified body and the responsible auditor. This helped us a lot!
Important topics are:
-Vigilance
-Post Market Surveillance: PMS, PSUR, PMCF
-UDI, MDRLabeling
It's always been my expectation that a massive number of MDD renewal and MDR original certificates will be issued on or about May 25, hopefully a result of efficiency, rather than procrastination.
I know that's how I'd do it. What companies need right now are not certificates, but tech file reviews and audits, so I'd focus single every resource I had on those, right up to the deadline. Then when time was finally too short for more reviews and audits, I'd queue up all the certificates and issue them en masse. I don't know exactly what that process looks like, but seems like it would be well suited for "en masse."
PS I'd be wildly impressed if one or more of the NBs had taken the opportunity to move away from paper certificates, but can't say I'm wildly optimistic.
I know that's how I'd do it. What companies need right now are not certificates, but tech file reviews and audits, so I'd focus single every resource I had on those, right up to the deadline. Then when time was finally too short for more reviews and audits, I'd queue up all the certificates and issue them en masse. I don't know exactly what that process looks like, but seems like it would be well suited for "en masse."
PS I'd be wildly impressed if one or more of the NBs had taken the opportunity to move away from paper certificates, but can't say I'm wildly optimistic.
