This guidance follows the approach set out in Guidance MDCG 2019-52 according to which ‘legacy devices’ should be understood as devices, which, in accordance with Article 120(3) MDR and Article 110(3) IVDR, are placed on the market after MDR or IVDR dates of application respectively and until 26 May 2024, or until the relevant certificate becomes void, if certain conditions are fulfilled.
- devices which are class I devices under Directive 93/42/EEC, for which a declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;
- devices covered by a valid certificate issued in accordance with Directives 90/385/EEC or 93/42/EEC prior to 26 May 2021;
- devices covered by a valid certificate issued in accordance with Directive 98/79/EC prior to 26 May 2022.
[Definition according to MDCG 2021-13 rev.1 Terminology]