Legacy devices

The transition depends on conditions set in Article 120, including the manufacturer's progress toward MDR certification. The guidance documents describe the categories of legacy devices and their end dates.

• ‘legacy devices’: this is considered to include all devices previously CE marked under the European Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2

Legacy devices should be understood as devices, which, in accordance with Article 120(3) of the MDR, are placed on the market after the MDR date of application (DoA) and until the end of the transition period laid down in Article 120(3) MDR 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.

MDCG 2022-21, Section 1.2, Terminology

‘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.

MDCG 2020-3 Rev.1, Section 1, Introduction (in line with MDCG 2021-25)

Legacy devices should be understood as devices, which, in accordance with Article 120(3) of the MDR, are placed on the market or put into service after the MDR’s date of application (DoA) and until either 31 December 2027 or 31 December 2028 if the conditions set in Article 120(3c) of the MDR 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.

MDCG 2021-25 Rev.1, Section 2.2, Terminology used in this guidance

MDCG 2020-6 uses the broadest reading, all devices previously CE marked under the MDD or AIMDD. MDCG 2022-21, 2020-3 and 2021-25 limit the term to devices placed on the market after the date of application under Article 120(3), and MDCG 2021-25 Rev.1 states the end dates of 31 December 2027 or 31 December 2028.