Anyone had an MDR technical file review/audit yet?

[Watchcat]

I know the NBs have been prioritizing (frantically) MDD renewals. I am not sure how MDR tech file reviews and audits have fit into their priorities and schedules so far. Has anyone here had one?

 

[sornas96]

Yes we had one. Whats your questions?

 

[Watchcat]

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.

 

[sornas96]

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

 

[Watchcat]

Thanks! As I'm sure you know, rumors abound, including with respect to timeframes. It seems like Elsmar offers an opportunity to find out more in the way of actual experiences and less in the way of dire predictions.

 

[RDSally]

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

Thanks! Can you tell, which aspects of UDI were reviewed at this phase, while UDI carrier is not yet a requirement (Date of application in 2021 earliest)?

 

[sornas96]

Thanks! Can you tell, which aspects of UDI were reviewed at this phase, while UDI carrier is not yet a requirement (Date of application in 2021 earliest)?

yes, that is correct and that was our assumption. But our NB was not interested in these transitional periods. That also surprised us a little bit. He wanted to see that we have already implemented the complete requirements for UDI.

 

[RDSally]

Ok, thanks a lot! I was planning on having a procedure ready in the QMS for UDI and Eudamed, but leaving implementation of the UDI carrier in labels for later...

 

[sornas96]

Yes, this is a very good preparation. We had created draft label for the TÜV. But you can also insert placeholders for symbols or UDIs (this was a suggestion of our NB).

 

[Watchcat]

Unfortunately we are still waiting for our certificate.

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.