MDCG 2020-18 MDCG关于眼镜镜片和Ready阅读器UDI分配的立场文件.pdf

Medical Devices Medical Device Coordination Group Document MDCG 2020-18 MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses Ready readers December 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. Medical Devices Medical Device Coordination Group Document 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. Article 27(3) MDR mandates that before placing a device, other than a custom-made device, on the market, th