Loss of certification because of outdated information in the Clinical Evaluation Report

Auxilium

Involved In Discussions
#1
Greetings,
I have a question which I stumbled over recently. Someone told me that the worst outcome of partially outdated information regarding clinical data in the Clinical Evaluation Report can lead to the loss of certification in the worst case.

Since I'm new to the fields of Regulatory Affairs, I wanted to get to know the insights of experienced people. Does this seem like a realistic threat?
The Clinical Evaluation Report that I'm speaking of contained 80% correct information and was definitely not completely outdated.
It's just a hard time for me to understand whether the non-updating of a section in the CER can possibly lead to this when the correct information about our clinical data also lies outside of our Technical Documentation within the company.

So my argumentation would be that the non-updating of the section in the CER would've probably not lead directly to the loss of our CE certificate if we really needed to explain to our auditor what's correct and what's not.

Are regulators really that strict? Or is it just me who has difficulties in understand the "different perspective of risk within the Regulatory Affairs departments"?
I feel like having different perceptions of risk is definitely a factor that can lead to rather heated arguments that ultimately lead to big disagreements and can make look people like me, who are willing to take more regulatory risks, into the corner of the "reckless" and "incompetent". For me, my decision making is generally speaking "weighing out lean implementation of regulatory requirements against business needs and business risks (e.g. loss of certification)". And frankly, I don't see the loss of certification coming so easily when in fact, you have had a very good relationship with the Auditor and your Notified Body.

I am really interested in your opinions and curious to learn! And if you have general other advice for me, I'm happy to hear that as well :)
Thanks!
 
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planB

Super Moderator
#3
My 2 cents: unless your recent post-market experience indicates that your not-yet revised CER takes wrong conclusions about the safety & performance profile of your device, I do not see how this issue could directly lead to a loss of your CE mark during a NB audit.
 
#6
Why not share it publicly? This forum is meant to help people, not drum business.
We are new to the forum and we are not able to post links yet. Not drumming business but if someone requires help with CER writing then we are going to try and help them.

The link is to a YouTube channel of Brandwood CKC that is not affiliated in anyway to us. The content may be of use to anyone. Hope this helps.
 

Auxilium

Involved In Discussions
#9
Thank you everyone for the answers.
This helps me categorize the statements about the loss of certification which was seen as a danger
 
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