Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All - 
I am going through the EU MDR and was wondering how is the Technical documentation (TD) expected. As Annex II gives us the guidelines on what is expected in the TD and Annex III mentions TD on Post Market Surveillance (PMS), my question is that if we have to mention Annex II and Annex III as a part of the same Technical Document body or should it be two different submissions altogether?
Any inputs are appreciated. Thank you.

https://connect.raps.org/rapseuropage/ourdiscussiongroup/viewthread?MessageKey=8859a436-2de6-4b9c-a5a0-a4b4c9bf243e&CommunityKey=4c625164-1b00-45fc-a5ce-b904b04f7dbe&tab=digestviewer#bm8859a436-2de6-4b9c-a5a0-a4b4c9bf243e

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 26-Aug-2019 11:58
From: Anonymous Member
Subject: EU MDR Technical Documentation Compilation

This message was posted by a user wishing to remain anonymous

Hello All -
I am going through the EU MDR and was wondering how is the Technical documentation (TD) expected. As Annex II gives us the guidelines on what is expected in the TD and Annex III mentions TD on Post Market Surveillance (PMS), my question is that if we have to mention Annex II and Annex III as a part of the same Technical Document body or should it be two different submissions altogether?
Any inputs are appreciated. Thank you.