Medical device CER (clinical evaluation report) according to MDR

#1
hello,
I'm looking for clinical evaluation report (CER) template according to the new medical device regulation (MDR) not Meddev 2.7 rev 4.
I'm also looking for templates for clinical evaluation plan , PMCF (post marketing clinical follow up)

could anyone help me?

thank you
sebastien
 

Rincewind

Starting to get Involved
#3
Looking at the MEDDEV and the MDR it seems, at least to me, they correspond very well and from my experience usually the notified body requests the CER structured according the MEDDEV 2.7/1 rev. 4.
So what exactly do you think is not covered by the MEDDEV?
 

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