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Exclusion of Medical Device Reporting of Components for Medical Systems

NewRegMan

Starting to get Involved
#1
Dear Cove

we are certified according ISO13485 as a supplier of components for medical systems (finished medical devices).
Our products are not medical devices!

ISO13485:2012 clause 8.5.1 says: If national or regional regulations require notification of adverse events that meet specific reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.

Can we exclude MDR and adverse event reporting/recall procedures from our Quality Manual since our OEM is responsible to report adverse events for medical devices?

Silly question eh?:eek:

Thanks for any valuable input.

Cheers
 
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S

SteveK

#2
Re: Exclusion of Medical Device Reporting

Probably a silly question.

What if you happen to find that one of your components is faulty (this may have been an item that had been supplied for some time and you have only just found out) and has been supplied to a number of companies without them being aware - do you just ignore it?

Steve
 

NewRegMan

Starting to get Involved
#3
Re: Exclusion of Medical Device Reporting

Thanks Steve

you're right, this scenario will be covered by one of our procedures. However the reporting to the authorities will be done by our OEM and we do not need e.g. contact the FDA or any other competent authoritiy, since we do not have a medical device.

Am I still on a wrong path?

Thanks again,
Guido
 
I

isoalchemist

#4
Re: Exclusion of Medical Device Reporting

I agree with you they can be excluded, just make sure you clearly document the reasons for the exclusion.

If it not a medical device and you do nothing to the medical device, i.e. repair where you may find the issue. The only potential issue is if your organization can "reasonably" be contacted to report a problem (such as your name and contact number being on your component). In that case you should probably have an escalation procedure to the OEM, but you should not need MDR/Recall reporting.:2cents:
 
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