On the 8th February 2021 the European Commission published a Guidance on the Management of the Legacy Devices. It explains in detail how Legacy Devices will be identified and the way their UDI will be generated/assigned. The content is quite technical, so for you to quickly understand the main lines of this guidance, we have summarized it here.
Recall: Legacy Devices are devices that are already legally on the market under MDD or the AIMDD, and still after the application of MDR or IVDR. Legacy Devices class I not sterile and/or with measuring function are not considered as Legacy Devices. They must be registered as Regulation Devices.
Legacy Devices are not subject to the assignment of Basic UDI-DI and UDI-DI. However, a primary identifier will be required (EUDAMED DI), as well as a device identifier (EUDAMED ID or UDI-DI if it exists). The EUDAMED DI has the same function as the Basic UDI-DI and is similar to the GMN (Global Model Number).
The generation of identification details is done according to the existence or not of a UDI-DI for a Legacy Device:
- UDI-DI already does exist:
- The UDI-DI can be used as the device identifier.
- Based on the UDI-DI, the EUDAMED DI is fully and automatically generated by EUDAMED.
- It will start with “B-” and be followed by the UDI-DI.
- UDI-DI doesn´t exist:
- Manufacturer must assign a EUDAMED DI and a EUDAMED ID, and respect a strict format (defined in the Annex 1 of the document).
- EUDAMED DI will start with “B-” .
- EUDAMED ID will start with “D-“. For the rest, it will have the same value as the DI.
- It is highly recommended to include the SRN in the EUDAMED DI, because if not, a same code could be assigned by 2 different manufacturer for different devices (dupplication -> this will generate an error message).
As a legacy device will become compliant with MDR or IVDR, it will be registered in the EUDAMED and become a Regulation Device. Then:
- if the UDI-DI already exists in the database for a Legacy Device, a link will be created with its successor, so that they will both share the same UDI-DI.
- if the Regulation Device is not exactly the same as the Legacy Device, the manufacturer must link them manually.
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