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

[RichardCooke]

MEDDEV 2.7.1 (rev 4) has introduced some changes to the process has anyone made a template that is usable

 

[Pads38]

Re: Clincal Evaluation

See here:

http://medicalsolutions.ul.com/clinical-evaluation-templates/

(Disclosure: No connections)

 

[RichardCooke]

Re: Clincal Evaluation

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.

 

[yodon]

Re: Clincal Evaluation

...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.

 

[mikinnear]

Re: Clincal Evaluation

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

 

[sebastien]

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

thank you

 

[Lokus200]

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

thank you

Working on it right now. MDR is a new topic, I believe that most people just started to work on it recently.