Legacy devices (IVDR)

IVDR legacy devices can stay on the market for a set period while the manufacturer works toward IVDR certification. IVDR requirements on post-market surveillance and vigilance already apply to them.

Legacy devices under the IVDR (hereafter ‘legacy devices’) should be understood as devices referred to in the 2nd or 3rd subparagraph of Article 110(3) IVDR, which are placed on the market or put into service after 26 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 Article 110(3), if the conditions laid down in the 1st subparagraph of Article 110(3) are fulfilled. Those devices can be: a) devices covered by a valid EC certificate issued by a notified body in accordance with Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) prior to 26 May 2022; or b) devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body.

MDCG 2022-8, Terminology used in this guidance