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๐ข An ๐๐ฝ๐ฑ๐ฎ๐๐ฒ ๐ผ๐ณ ๐๐ต๐ฒ ๐ ๐๐๐ ๐ฎ๐ฌ๐ฎ๐ฌ-๐ฏ ๐๐๐ถ๐ฑ๐ฎ๐ป๐ฐ๐ฒ on ๐๐ถ๐ด๐ป๐ถ๐ณ๐ถ๐ฐ๐ฎ๐ป๐ ๐ฐ๐ต๐ฎ๐ป๐ด๐ฒ๐ ๐ถ๐ป ๐ฟ๐ฒ๐น๐ฎ๐๐ถ๐ผ๐ป ๐๐ผ ๐๐ต๐ฒ ๐๐ฟ๐ฎ๐ป๐๐ถ๐๐ถ๐ผ๐ป๐ฎ๐น ๐ฝ๐ฟ๐ผ๐๐ถ๐๐ถ๐ผ๐ป ๐ผ๐ณ ๐๐ฟ๐๐ถ๐ฐ๐น๐ฒ ๐ญ๐ฎ๐ฌ ๐ผ๐ณ ๐๐ต๐ฒ ๐ ๐๐ฅ has been published for medical devices certified under the MDD or AIMDD..
๐ This guidance establishes the reference framework for determining any change that ๐ญ๐ฆ๐จ๐ข๐ค๐บ 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.
โ๏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;โ๏ธ devices covered by a valid EC certificate issued under the AIMDD or the MDD before 26 May 2021.๐๏ธ๐๏ธThe 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
https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf
