MDCG指南——客户定制类医疗器械问答.pdf

Medical Devices Medical Device Coordination Group Document MDCG 2021-3 MDCG 2021-3 Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices March 2021 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. 1 Medical Devices Medical Device Coordination Group Document MDCG 2021-3 Introduction This Q&A is a high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR). Further guidance on this subject may be elaborated by the MDCG, as appropriate. In accordance with Recital 5 of the MDR, certain references to International Medical Device Regulatory Forum (IMDRF) guidance documents and terminology included therein have been taken into account under this Q&A. Specifically, the MDR regulatory status of adaptable medical devices and patient-matched medical devices (introduced by IMDRF PMD WG/N49 FINAL: 2018) is clarified in this Q&A. 1. What is a custom-made device (CMD)? MDR Article 2(3) defines a ‘custom-made device’ as any device that: − is specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's