Jun 1, 2021

The European Commission’s Medical Device Coordination Group (MDCG) published MDCG 2021-09: MDCG Position Paper on the Implementation of UDI Requirements for Contact Lenses, Spectacle Frames, Spectacle Lenses & Ready Readers. This position paper aims to provide clarity to manufacturers of the products listed in the title on how to apply Unique Device Identification (UDI) requirements under the EU Medical Devices Regulation 2017/745 (MDR).

Specific UDI assignment solutions are not yet in place for these optical products

The paper begins by summarizing general medical device UDI requirements as laid out in the Articles of the MDR; it notes that for certain healthcare products that are highly individualized, specific UDI assignment solutions are planned. The MDCG has already agreed upon an assignment scheme applying to spectacle lenses and ready readers, but it has yet to work out the practical details of its implementation. The MDCG UDI Working Group is currently in the process of developing a separate UDI assignment solution for contact lenses, which it is likely to extend to spectacle frames.

Manufacturers advised not to voluntarily register designated medical devices in Eudamed yet

Given these circumstances, the MDCG offers this guidance to manufacturers of contact lenses, spectacle frames, spectacle lenses, and ready readers:

  • These products should be compliant with general UDI assignment requirements given in the MDR until specific assignment solutions become available.
  • Since UDI carrier labeling requirements do not apply to most of these products until May 2023 (for Class IIa and IIb devices) or May 2025 (for Class I devices), there should be time to wait until specific UDI assignment solutions are available before designing carrier labels.
  • Provision of Basic UDI-DI and other core data elements will be required for medical devices starting 24 months after the publication of notice that the Eudamed database is fully functional. Manufacturers of the aforementioned optical products are instructed to wait until this time, or such time as specific UDI assignment solutions are finalized, before voluntarily using the UDI/Device registration module of Eudamed to register their devices or input UDI information for them.

More resources on EU MDR compliance from Emergo by UL:

  • European MDR preparation and compliance resource center
  • European Authorized Representative in-country representation
  • Whitepaper: Extended MDR date of application—optimizing your PMS and clinical activities
  • Webinar: Europe’s new Medical Devices Regulation (MDR)
  • Webinar: Eudamed requirements under the MDR and IVDR

Author

  • Timothy Herr

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