EU: Propose “Master UDI” As A Single Identifier For Highly Individualized Medical Devices

ARQon
Apr 6, 2023
1 min read

The concerns about highly disproportionate numbers of identifiers in the European Database of Medical Devices (EUDAMED) have risen due to the highly individualized level for some medical devices. The center of attention of discussion at both EU and international levels are contact lenses, as one of the highly individualized devices. Discussions found that some similar details and parameters can be combined under one group.

After numerous experiences of implementation issues in the UDI system, the Medical Device Regulation (MDR) was expected to release an exemption for manufacturers importing data into the UDI database. Unfortunately, no exemption was granted for the highly individualized devices.

Hence, the European Union opens an initiative proposal called “Master Unique Device Identification Device Identifier (Master UDI-DI) on 22 March 2023. The main intention is to gather all highly individualized devices with the same parameters under one identifier called Master UDI-DI.

The new system initiative is expected to improve the traceability and accountability of EUDAMED and hopefully, the outcome will help to smoothen the plan of extending the scope for other highly individualized devices in the future.

The Commission opens the draft proposal for 4 weeks, starting 22 March 2023 until 19 April 2023.

Source: European Commission