MDCG 2022-18 ADD.1 - Application of Article 97 MDR to legacy devices ⚡

Written By MDRG

A new addition to the EU MDCG guidance 2022-18 has been published, addressing the implementation of Article 97 of the MDR for legacy devices that have MDD or AIMDD certificates expiring before obtaining an MDR certificate.

 

🔗 Original Document:  https://health.ec.europa.eu/system/files/2023-06/mdcg_2022-18_add-1_en.pdf

MDRG
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