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

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.

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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...

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