Hello,
Erik is correct there is a nice summary in the MDCG document. However, just caution there are many aspects of the QMS and even technical documentation which we are seeing Notified Bodies applying toward existing products on the market (products with EU MDD certification). The level of regulatory review of technical documentation, clinical evaluation, risk management, process monitoring and measuring, etc., are all on the level of EU MDR compliance.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Dec-2021 03:44
From: Erik Vollebregt
Subject: List of EU MDR articles to comply with since May 2021 for legacy devices
MDCG 2021-25 contains a pretty complete list on pages 9-11: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 27-Dec-2021 08:55
From: Anonymous Member
Subject: List of EU MDR articles to comply with since May 2021 for legacy devices
This message was posted by a user wishing to remain anonymous
Hi,
do we want to use this topic to list all EU MDR articles manufacturers with CE certificates issued under MDD have to comply with since May 2021?
I am referring for example to the Post-Market Surveillance requirements that have immediately to be taken into account...