The European Commission has agreed to amend the EU Medical Device Regulation (MDR) to ease the Unique Device Identifier (UDI) requirements for certain products, starting with contact lenses. Once adopted, the regulation will allow contact lens manufacturers to assign a Master UDI-DI to certain products instead of a UDI-DI.
On 10 July, the Commission adopted a Delegated Regulation that would allow standard contact lenses and made to order contact lenses with the same design parameters to be grouped under one Master UDI device identifier (UDI-DI). The change is meant to help lower administrative burdens for manufacturers that are otherwise available in other jurisdictions.
In a memorandum explaining its decision, the Commission said that after years of experience implementing its UDI regulations, regulators realized that the current UDI requirements may be unnecessarily burdensome for certain products. Creating the Master UDI-DI system is meant to reduce burdens in those cases…
