The European Commission Is Now Seeking Public Input On Its Draft Delegated Act

A public consultation has been launched by the European Commission (EC) on its’ draft delegated act for highly individualized devices. The delegated act establishes the Master UDI-DI, a new identifier intended to group highly individualized devices according to clear clinic parameters.

The Master UDI-DI solution was developed to reduce the volume of device records submitted to EUDAMED for contact lenses. However, the solution may be applied to other highly individualized devices in the future.

HIBCC labelers are encouraged to respond to the consultation as the new delegated act may change the UDI requirements for certain devices. The consultation can be accessed at the link below and responses can be submitted until April 19th, 2023.

To view the EC’s Master UDI-DI Consultation  click here.

To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at udisupport@hibcc.eu or +1 (602) 381-1091.