“Legacy devices” are medical devices, covered by a valid Medical Device Directive certificate (Declaration of Conformity for class I medical devices) – which continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR).
According to Art 120(3) of the MDR also legacy devices must lay down to the requirements relating to the registration of economic operators in EUDAMED, the European medical device database. Legacy devices are not subject to the traceability requirements linked to the Basic UDI-DI and UDI-DI.
However, Basic UDI-DI and UDI-DI are considered necessary by the EUDAMED system in order to proceed with the registration.
MDCG guideline 2019-5 provides all the needed clarifications useful to solve this issue. According to MDCG guideline 2019-5 legacy devices can be registered in EUDAMED in absence of a basic UDI-DI; an Eudamed DI will be assigned to the device instead of the Basic UDI-DI and a Eudamed ID will be assigned by Eudamed instead of the UDI-DI allowing the system to work and to keep the design of Eudamed as close as possible to the MDR design. These Eudamed DI and Eudamed ID will be unique for a given legacy device.
RPN is available to provide any updates on the medical device regulatory framework and to assist on all regulatory needs.
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