Changing Notified Body

#1
Does anyone have insight into changing Notified Bodies between the MDD and MDR? We're unhappy with the responsiveness, or lack thereof, from our current NB (example: audit was in February, they didn't review our CAs until April, and haven't done the PE review for the VoEs which they've had since early August, and our certs expire end of October)

How cumbersome would it be to maintain the MDD with our current NB and pursue the MDR with a different one? Would it make sense to transfer our ISO 13485 cert from the current NB to a new one?
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
You can change but it's likely you will experience the same issues at another NB. NB are swamped right now. MDR (And to some extent Brexit)is a huge learning curve and there are fewer NB to go around by about 50%. They are prioritizing larger accounts (Most likely) and smaller firms are suffering. I put in an RFQ for MDSAP in late August and still have no response. We will submit for MDR in October but informed my CEO it's possible we don't receive a submission slot until early 2022.

2 years ago an EU company was auditing us and I said that many products will drop off the EU market with the new tighter restrictions; they said they were aware and ok with that result.
 

Philip B

Quite Involved in Discussions
#3
I agree with Ed's comments. The chances of you finding a new NB prepared to take you on in the current climate are slim and the chances of them being better than your current NB are equally slim.

We submitted our technical documentation for MDR transition in August and I still don't have a date from our NB for when they will check they have all of the documents, let alone audit the documentation. Our MDD certificate expires in June and I'm already worried that we will run out of time.
 
#4
We're in a unique situation - we have clearance/licenses in US/CAN/EU, but only actively market in the US. Everything else is just an exercise in case we strike an acquisition deal.

I can't imagine many companies would continue to pursue the MDR unless they had to, but here I am. I've tried to persuade the rest of senior management that it's not worth it for us, but to no avail.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#5
We're in a unique situation - we have clearance/licenses in US/CAN/EU, but only actively market in the US. Everything else is just an exercise in case we strike an acquisition deal.

I can't imagine many companies would continue to pursue the MDR unless they had to, but here I am. I've tried to persuade the rest of senior management that it's not worth it for us, but to no avail.
We are identical. A small start up and we are leveraging our FDA clearance to other markets, although we did also MDD in EU last year under the timer.

Canada we are approved under the Interim Order for COVID and we also leveraged FDA for Australia.

Being small requires being nimble because its harder to turn away business. I think larger companies are more strict in strategy and tactics.
 
Last edited:

monoj mon

Quite Involved in Discussions
#6
I would also advice to stick to the same NB as your situation with NB is not unique, most of the companies are facing it with different different NBs. As you are not present in the EU market, even if you receive your MDR certificate after the expiration of your MDD certificate it should not affect your business much (or at all !).

I am wondering why is your MDD certificate expiring this year! Wasn't it suppose to last until 2024!
 

Billy Milly

Involved In Discussions
#7
I am wondering why is your MDD certificate expiring this year! Wasn't it suppose to last until 2024!
Certificates last until they expire, max 5 years from issuance. NBs extended their validity on request (and of course not for free) before DoA - no request, no extension...

Regarding the change of NB, I would agree with the advice above. If you have a functional NB (to be or maybe even already MDR designated), stick to it. I would go into change only if there is a strong mutual interest on both sides (reaching further than € and certificate).
 
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