The Medical Device Coordination Group (MDCG) provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746. “Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices” 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).
March 26, 2021