Only 'legacy devices' can benefit from the extended transitional period. In line with MDCG 2021-252 'legacy devices'
should be understood as devices, which, in accordance with the MDR's transitional provisions, are placed on the
market after the MDR's date of application (i.e. 26 May 2021) if certain conditions are fulfilled. Those devices can be:
• devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC 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 EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD
prior to 26 May 2021.
The extension of the transitional period beyond 26 May 2024 only applies if the conditions laid down in Article 120(3c)
MDR are fulfilled. In case of devices for which the relevant certificate has expired before 20 March 2023, also the
conditions laid in the second subparagraph of Article 120(2), points (a) or (b), MDR need to be fulfilled (see below
part C).
The Commission will make available flowcharts to assist manufacturers and other relevant actors in deciding whether
or not a device is covered by the extended transitional period provided for in Article 120 MDR.