Europe – MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers

Article 27 of Regulation (EU) 2017/745 on Medical Devices (MDR) introduces a Unique
Device Identification (UDI), which among other functions aims to improve the
identification of devices and enhance the effectiveness of post-market safety-related
activities for devices. This position paper is intended to provide clarification on UDI
assignment obligations for manufacturers of Spectacle lenses & Ready readers. It
should be read in conjunction with the relevant provisions of Regulations (EU)
2017/745 (notably Chapter III and Annex VI) and related UDI guidance documents.
Article 10 (7) MDR mandates that manufacturers shall comply with the obligations
relating to the UDI system referred to in Article 27 and with the registration obligations
referred to in Articles 29 and 31 of the MDR…