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Regulating Custom-Made Devices Under EU MDR – Clear Distinctions To Replace Overlap Confusion

 
• By Amanda Maxwell

EU level guidance has been issued on custom-made devices (CMDs), adaptable medical devices and patient-matched medical devices. It should help clarify how to regulate devices which lie on the borderline between needing to fully comply with the EU's MDR and those that eligible for some regulatory exemptions as CMDs.

exoskeleton adapted to the human hand

An eight-page Q&A document, endorsed by the European Commission’s Medical Device Coordination Group, helps clarify the nuanced differences between CMDs, adaptable medical devices and patient-matched medical devices and the necessary regulatory approaches according to their precise definition.

The text also examines the area of overlap between materials used in both CMDs and medical devices that undergo the full CE-marking

What Makes A Device A Custom-Made Device?

The Q&A starts by defining what constitutes a CMD. It cites MDR Article 2(3) as any device that:

  • Is specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person's professional qualifications;

  • Gives specific design characteristics provided under that person's responsibility; and

  • Is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs

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