EU Device Group Answers Questions on Custom-Made Devices in EU MDR

The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A document to help answer questions relating to custom-made devices covered under the EU Medical Device Regulation (MDR).

MDR defines a custom-made device as any device that is specifically made in accordance with a written prescription from an authorized person, which gives specific design characteristics and is intended for the sole use of a particular patient exclusively to meet their individual needs.

Examples of custom-made devices include dental crowns, or a prosthesis intended to replace a lost body part or function where the physician provides patient-specific design characteristics necessary for the manufacturing of the device, the MDCG said.

Devices not considered custom-made devices are mass-produced and need to be adapted to meet the specific requirements of the user.