Master UDI-DI registration for EUDAMED
The use of the EUDAMED UDI/Device Registration Module will become mandatory in early 2026, six months after the European Commission’s publication in the Official Journal of the European Union. We will communicate further on this once a final date has been announced by the European Commission.
However, for devices presenting a high level of individualisation, notably contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles, and in order to adapt the UDI-DI assignment criteria to such kind of devices, the assignment of a Master UDI-DI has been foreseen.
The timeframe for these devices is slightly different:
Spectacles
As recently established in Commission Delegated Regulation of 12 June 2025, the Master UDI-DI solution must be implemented by manufacturers of spectacle frames, spectacle lenses and ready-to-wear reading spectacles as from September 2028, three years after the entering into force of the act.
The obligation to label the Master UDI-DI and register those devices in the UDI/Device registration module of Eudamed follows the Master UDI-DI assignment obligation, with time laps spanning from about 10 months for contact lenses to about 30 months for spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
From 26 May 2025 until the Master UDI-DI solution is fully available (i.e. through the relevant Commission Delegated Regulations and the appropriate EU UDI issuing entity standard), these highly individualised devices will continue to be identified with either an issuing entity identifier or similar internal manufacturer device identifier as for the current procedures.
If you have any questions regarding EUDAMED, UDI-DIs, Basic UDI-DIs, or the Master UDI-DI, please do not hesitate to contact our specialists for further guidance.
