Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template


Inactive Registered Visitor
:thanx:MEDDEV 2.7.1 (rev 4) has introduced some changes to the process has anyone made a template that is usable
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Inactive Registered Visitor
Re: Clincal Evaluation

:thanx:Thank you Pads38. I had seen those previously but they are a bit too FDA for what our auditors want (I did show it to them) I was hoping for something that has been tested in an audit within the EU.


Super Moderator
Re: Clincal Evaluation

:thanx:...they are a bit too FDA for what our auditors want ....

I'm curious why you / your auditor thinks that? Just looking at the TOC for each, it looks like they fall exactly in line with 2.7/1 revision 4.


Starting to get Involved
Re: Clincal Evaluation

@Pads38 - this resource has moved, does anyone have an updated document?


does anyone have CER, CEP and PMCF templates according to MDR?

thank you
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