The European Commission’s Medical Device Coordination Group (MDCG) has issued a new guidance in the form of a Q&A document, introduced as being 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)”.
The document is titled MDCG 2021-3 ‘Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices’. Custom-made devices (CMDs) are defined under MDR as devices made specifically in accordance with a written prescription by an authorized person that have specific design characteristics and are intended for the sole use of a particular patient to address their individual condition and needs.
Examples of CMDs include dental crowns or hand prostheses made with specific design characteristics for an individual patient. Mass-produced devices that are adaptable to meet the requirements of professional users (adaptable devices) and those that are made via industrial manufacturing processes in accordance with a written prescription (patient-matched devices) are not considered CMDs and must follow the standard pathway for being placed on the market under MDR.