Was sind "Bestandsprodukte" im Kontext von Medizinprodukten?

"Legacy devices" in the context of the MDR are defined by the Medical Device Coordination Group (MDCG) as medical devices which, after the date of application of the MDR (26 May 2021) and until at the latest 31 December 2027 or 31 December 2028 (depending on the fulfilment of the conditions set out in the transitional provisions of Article 120(3c) MDR), may continue to be placed on the market or put into service, even though they are still certified under the previous Directives (MDD 93/42/EEC or AIMDD 90/385/EEC) and are not fully compliant with the MDR.

How are "legacy devices" defined?
According to MDCG 2021-25, "legacy devices" include:

• Class I devices under the MDD for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which, under the MDR, the involvement of a notified body would now be required;
• Devices covered by a valid certificate issued by a notified body under the MDD or AIMDD before 26 May 2021.

A precise definition and interpretation of the term "legacy devices" is provided in guidance document MDCG 2021-25. There, such products are described as those which, after the date of application of the MDR (26 May 2021) and under certain conditions, may continue to be placed on the market even though they are still certified under the previous Directives. However, this only applies as long as no "significant changes" are made to the design or intended purpose of the device.

Furthermore, it is required that these devices, during the transitional period, comply with numerous MDR requirements, in particular those relating to market surveillance, vigilance, registration, and post-market surveillance (PMS).

Do you require a clinical evaluation or clinical investigation for your legacy device? We are happy to support you. Please feel free to arrange an initial, non-binding consultation with us. We are here for you!

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Reference; MDCG 2021-25: "Guidance on legacy devices under MDR Article 120" (European Commission, Medical Device Coordination Group)