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IMDRF Issues Guidance On Personalized Medical Devices In Response To Tech Advancements

 
• By Amanda Maxwell

Given that it is now possible to produce individualized medical devices on a commercial rather than an artisanal scale, new measures are needed to keep up with the changing level of risk to patients.

Doctor woman sitting with male patient at the desk

How should the design of personalized medical devices be regulated when the breadth of variation makes it impossible to fully assess compliance? And how should the production system be regulated for such devices, given the large number of permutations that could occur?

This global conundrum is being tackled in a pre-market application guidance document from the International Medical Device Regulators Forum (IMDRF)...

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More from International

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At LSX World Congress USA, medtech executives shared lessons on global expansion, from regulatory pitfalls to cultural nuances and funding gaps. Their message: Prepare early, secure capital, and choose partners wisely.

More from Geography

Medicare’s TCET Pathway Wins Acclaim From Early Users, Even As ‘Messy Middle’ Persists

 
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Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.

German Medtechs Choking Under EU Compliance And Reporting Obligations Tout Mutual Recognition

 
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Fixing The Fractures: New Aspirations For EU Medtech Regulatory Progress

 
• By Amanda Maxwell

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