Subject: ASR report for pre-market medical device study in Estonia query
From: "Chevalier, Aleksandra" <[email-masked]>
To: "TA Info" <[email-masked]>
Date: Wed, 3 Apr 2024 17:55:35 +0300

Dear Sir/Madam, 
 
Hope this email finds you well. 
 
We would like to confirm two topics related to pre-market device studies
in Estonia.
 
1.  Could you please provide reference from MDR on the content of ASR
report for pre-market device study in Estonia?
 
2.  Our Sponsor have decided to have 1 ASR per product per protocol per
country. Could you please verify/confirm there is no regulation in Estonia
or Europe (MDR 745-20017 requirement) against this decision? 

Thank you 

 
Best Regards, 
 
Aleksandra Chevalier, MPharm 
Drug Safety Associate, Drug Safety 
 
E: [email-masked]
fortrea.com
Fortrea Development Ltd 

 

 
 
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