May 15, 2023

New update of MDCG 2020-3 significant changes for devices under MDD

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๐Ÿ“„ This guidance establishes the reference framework for determining any change that ๐˜ญ๐˜ฆ๐˜จ๐˜ข๐˜ค๐˜บ devices may undergo, taking into account Regulation (EU) 2023/607, which establishes that devices that continue to comply with the AIMDD/MDD may be placed on the market or put into service until 31 December 2027 or 31 December 2028, as applicable, provided that the conditions laid down in Article 120(3c) are met.

โœ”๏ธ class I devices (MDD), for which an EC declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;โœ”๏ธ devices covered by a valid EC certificate issued under the AIMDD or the MDD before 26 May 2021.๐Ÿ–‹๏ธ๐Ÿ–‹๏ธThe conditions laid down in Article 120(3c) of the MDR include, among others, that legacy devices must continue to comply with the AIMDD/MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device.

You can obtain this guidance here ๐Ÿ‘‰

https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf