Eudamed identification requirements for legacy devices
While legacy devices will ultimately fall under MDR and IVDR registration requirements, they may not necessarily have to comply with the Regulations’ identification requirements to be assigned Basic UDI-DI and UDI-DI codes.
Under the MDR, the Basic UDI-DI is defined as the primary identifier of a device model, and the main identifier for records in Eudamed; the UDI-DI code is specific to a model of device, and used as an access key to data stored in Eudamed. In some instances, legacy devices have already been assigned UD-DI codes, which may be used for Eudamed registration and identification purposes.
However, some legacy devices will need identification elements known as Eudamed DI codes, which will function as equivalents to Basic UDI-DI codes for purposes of maintaining identification elements across all devices (legacy or otherwise) registered in the Eudamed database. In cases where a legacy device has had no UDI-DI assigned to it, a Eudamed ID will be generated and assigned for that device based on its Eudamed DI.
(Annex 1 of the new European Commission document provides in-depth format requirements for Eudamed DI codes.)
European Commissioners are conducting a phased implementation of the Eudamed database, with a target final date of application set for May 2022. Eudamed’s UDI and device registration module is anticipated to launch in May 2021.
Additional European MDR, IVDR and Eudamed compliance resources from Emergo by UL:
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