“Legacy devices” represent devices, which are placed on the market or put into service AFTER 26th May 2022 (i.e. the IVDR’s date of application) and until the end of the respective transition period set out in the 2nd or 3rd subparagraph of the IVDR Article 110(3), if the conditions laid down in the 1st subparagraph of the article are fulfilled. Those devices can be:
a) devices covered by a valid EC certificate issued by a notified body in accordance with the IVDD prior to 26th May 2022; or
b) devices for which a declaration of conformity was drawn up prior to 26th May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body.
“Old devices” are those devices that were placed on the market or put into service BEFORE 26th May 2022 in accordance with the IVDD and which are still on the market or in use after 26th May 2022.
In this guidance, you can find the requirements to “legacy devices” under the IVDR, including a table illustrating which IVDR requirements are applicable to “legacy devices” and which are not. For instance, the requirements relating to post-market surveillance, market surveillance, vigilance and so on.
Attachment: MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022
MDCG 2022-8 - Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022