European Commission approves updated regulation to ease contact lens UDI requirements
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.
“Experience gained through the setting up and implementation of the UDI system in the EU and in other jurisdictions internationally shows that certain devices present a high level of individualization (‘highly individualized devices’), resulting in a disproportionate level of granularity and UDI-DIs which would need to be reported in UDI databases e.g. Eudamed in the EU,” the Commission said in the memorandum. “In comparison with other medical devices, the numerous possible clinical parameter combinations cause a level of granularity not needed for regulatory purposes.”
The Commission notes that they’re not alone in facing problems trying to implement a UDI system for products such as contact lenses, but other jurisdictions can grant exemptions to manufacturers of highly individualized devices so that they are not required to report UDI-DI in their UDI databases.
“The MDR does not provide for the possibility to grant such an exemption in the EU,” the Commission said. “Therefore, in order to resolve the implementation issue and allow for proportionate UDI-DI data entries in Eudamed, the ‘Master UDI-DI’ has been developed by the Commission in close collaboration with regulators and relevant stakeholders, including industry, contact lenses experts and EU issuing entities.”
The Commission goes on to state that the Master UDI-DI is meant to be used as the identifier for groups of highly individualized devices that have similar clinically relevant parameters. While the updated regulation now only covers contact lenses, more products may be eligible to use the Master UDI-DI system.
“Whilst in the future the Master UDI-DI solution could be extended to other highly individualized devices, at present the focus remains on contact lenses,” said the Commission. “Should the need arise, the Commission will propose a new delegated act to extend the Master UDI-DI solution to other devices.”
While the Delegated Regulation is set to go into effect 20 days after it is published in the Official Journal of the European Union, manufacturers can already start assigning Master UDI-DI’s to their products.
Delegated Regulation
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