France clinical trial requirements

itscloud

Starting to get Involved
#1
Hi,

Looking for a link to the official clinical trial requirements to be conducted in France, had a look in ANSM but could not understand French

Thanks
 
Elsmar Forum Sponsor
#2
Hi,

Looking for a link to the official clinical trial requirements to be conducted in France, had a look in ANSM but could not understand French

Thanks
Dear itscloud, the link 1631868670436.png
on ANSM website is a translation of the page 17 of MDCG-2021-6 and the link 1631868670436.png
provides the MDR requirements on table format with the advantage to provide the email adress to submit the incidents in France waiting for Eudamed.
 

Attachments

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