Europe – MDCG 2021-3 : Questions and Answers on Custom-Made Devices

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…