MDR - Is a formal GSPR Procedure required?

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Ronen E

Problem Solver
Staff member
Moderator
#12
Perhaps what you can do is add a small section to your existing regulatory compliance procedure
"Regulatory compliance procedure"?... Where did that come from? Not something I would automatically assume every manufacturer has. Regulatory compliance is an area, maybe a set of processes, not a procedure. To me it makes as much sense as having a Quality Assurance procedure or an Engineering procedure. It's not impossible, but does it makes sense?
 

James

Involved In Discussions
#13
Hi.

I was wondering if people have created a GSPR procedure for the MDR? This was a point during an MDR Upgrade Assessment and I was wondering if people had written a formal procedure against this?

I appreciate that we have to provide a checklist as evidence but is a procedure required?

Thanks.
I've created a system-wide GSPR checklist which identifies where each clause is managed in our system, and included a significant section of the GSPR in product family technical files. This should help us quickly identify how we comply if asked (by our responsible authority moreso than 13485 auditor)

Cheers

James
 
#14
I have level 2 document named "Compilation of Technical File" where all necessary documents and its contents are summarized in a table. GSPR checklist form is referred here.
 

MakingADifference

Involved In Discussions
#15
No 'shall' so not a non-conformance at all. But it doesn't hurt to take a few minutes to 'future proof' against wayward auditors and wasting time going through verbal battle(s) again.
I am all for future proofing and happy to include something in our quality manual etc to make it clear, but....... I am not happy!

This has been raised as a Major NC. I am formally appealing as it is crazy.
 

pziemlewicz

Involved In Discussions
#16
This has been raised as a Major NC. I am formally appealing as it is crazy.
The only way this could be major nonconformance is if you ignored GSPR altoghether. If you have covered the required content somewhere, you should be able to get out of the finding (unless of course the auditor has already left and finalized report).
 

MakingADifference

Involved In Discussions
#17
The auditor has already left and although the report is not finalised, they are sticking to this being a major because their checklist says that there should be a procedure!

There is supporting evidence but not a specific procedure as required by the standdaaa, scrap that.. Their checklist!
 

James

Involved In Discussions
#18
There is supporting evidence but not a specific procedure as required by the standdaaa, scrap that.. Their checklist!
There doesn't need to be documented information per se so it will be interesting to see how your appeal is managed. Compliance with relevant legislation is obviously a factor in their rationale, but that could surely only result in an advisory until May 26th anyway? Curious...
 
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