SPECTARIS and EUROM Optical Industries provide clarification in the MDR deadline jungle

Legal uncertainty prevented: A conflict of objectives in the EU Medical Devices Regulation (MDR) would have forced manufacturers of eye care products such as contact lenses, spectacle lenses, spectacle frames and ready-made reading glasses into illegality through no fault of their own. Now this situation has been clarified.

The background to this was a contradictory deadline situation: the obligation to register in the EU database EUDAMED was to take effect earlier than the possibility of implementing the necessary UDI labelling – in particular the Master UDI-DI – in a technically and legally compliant manner.
Depending on the product category, manufacturers would have been effectively forced to violate applicable requirements for a period of up to 30 months. Sanctions or recalls as part of an audit could have been imposed, even though implementation would have been impossible in practice.

Associations provide clarity

Only through the decisive action of the trade associations Consumer Optics within the industry association SPECTARIS and the European umbrella organisation EUROM Optical Industries was it possible to successfully address the problem with the EU Commission. The result: an official position paper now provides clarity and urgently needed legal certainty.

EU Commission position paper: Registration possible before the deadlines

The MDR requires UDI labelling for all products, including the Master UDI-DI for highly customisable products such as contact lenses, spectacle lenses, spectacle frames and ready-made spectacles. The Master UDI-DI allows similar product versions from one manufacturer to be grouped under a single identifier.
The Commission has now clarified that if the technical solution is available early, manufacturers may label their products with a Master UDI-DI and register them in EUDAMED before the official deadlines – but they are not required to do so.
This enables legally compliant and audit-proof implementation. Alternatively, it remains permissible to label products with an identifier from a designated issuing entity (e.g. GS1) or a comparable internal manufacturer identifier until the mandatory Master UDI deadline, as has been the case to date. For these product categories, registration in EUDAMED is therefore not mandatory until the respective deadline. The binding Master UDI deadline is 9 November 2026 for contact lenses and September 2028 for eyeglass products (e.g. frames, lenses, ready-made reading glasses).

Success for the industry

This clarification represents an important step towards legal certainty and planning clarity for optical manufacturers across the EU. It will enable the MDR requirements to be implemented on time, particularly with regard to testing and audit situations with supervisory authorities.

The clarifying EU position paper was published on the EU Commission website.

If you have any questions, please contact Carsten Leutloff at leutloff@spectaris.de or Aziza Arbabzadah at arbabzadah@spectaris.de