Management of Legacy Devices in Eudamed

Official document of the European Union on how to identify legacy devices in Eudamed

What are Legacy Devices?

Legacy Devices are Medical Devices, Active Implantable MDs and In Vitro Diagnostic MDs which are covered by a valid certificate issued in accordance with the respective MDDs (Directive 93/42/EEC, Directive 90/385/EEC, Directive 98/79/EC) and that continue to be placed on the market after the date of application of the MDR/IVDR (Regulation (EU) 2017/745 (MDR)/Regulation 2017/746).

Registration in Eudamed:

The registration in Eudamed of Legacy Devices is possible, but mandatory in case of a serious incident or if a field safety corrective action applies, which requires registration as soon as possible and at least before a follow up or final vigilance report is submitted.

Furthermore, if 18 months after the date of application of the MDR or IVDR (or 24 months after the date of publication of the notice referred to in Article 34(3) if EUDAMED is not fully functional before the date of application of the MDR), the equivalent device is not made compliant and registered as a MDR or IVDR device, the Legacy Device must be registered in EUDAMED within this time period.

Devices compliant to the Directives with the risk class I that are not sterile and/or with a measuring function cannot be considered as Legacy Devices because they do not require a certificate issued by a Notified Body. Such Devices must be registered only as Regulation Devices in EUDAMED within the 18 months after the date of application (or 24 months after the date of publication if EUDAMED is not fully functional).

Assignment of a Basic UDI-DI and a UDI-DI

To keep the same structure and identification elements for all Devices registered in EUDAMED, an identification element EUDAMED DI (equivalent of Basic UDI-DI) will be required, and a EUDAMED ID (if no UDI-DI has been assigned) will be generated from the EUDAMED DI.

The Basic UDI-DI will never be applicable and never be assigned to a Legacy Device, only EUDAMED DI, the UDI-DI can be used to identify a Legacy Device in EUDAMED.

Only one device identifier will be assigned to a Legacy Device, either a UDI-DI (where the EUDAMED DI is automatically generated) or a EUDAMED DI (where the EUDAMED ID is automatically generated).

The official document contains flowcharts and examples to better understand how to register and identify your devices in EUDAMED.

Get it here: See link below