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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...

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Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

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• By Amanda Maxwell

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• By Ashley Yeo

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Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

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More from Geography

Johnson & Johnson MedTech: How To Scale Digital Solutions

 
• By Natasha Barrow

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

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• By Natasha Barrow

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• By Natasha Barrow

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