Legacy device is the semi-official term for medical devices that were not placed on the market in accordance with the EU MDR, but rather on the basis of the outdated MDD 93/42/EEC or AIMDD 90/385/EEC.
Article 120 of the MDR regulates the transitional provisions for such devices, but the EU MDR does not use the term ‘legacy devices’. However, a functional definition can be found in the MDCG Guidance Document 2021-25 Rev. 1. It states:
„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.„
These may be devices that are Class I devices in accordance with Directive 93/42/EEC (MDD), for which an EC declaration of conformity was issued before 26 May 2021 and for which the conformity assessment procedure in accordance with the MDR requires the involvement of a notified body.
This may also include devices for which a valid EC certificate has been issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD.
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