Target Audience Manufacturers
Products concerned Spectacle lenses and ready readers
Documents mentioned MDR (EU) 2017/745

Article 10(7)

Chapter III : Article 27, Article 27(3), Article 29, Article 31

Annex VI


In this document, the Medical Device Coordination Group (MDCG) clarifies the allocation of the basic UDI-DI and the UDI-DI for spectacle lenses and ready readers. Manufacturers of these types of products must comply with this MCDG, in addition to the requirements for the UDI mentioned in Regulation (EU) 2017/745.