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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 Geography

Prosthetics: Firms Like Unhindr And Esper Shape Market On the Cusp of Great Change

 
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India Sets Sights On ‘First-In-World’ Medtech Innovation

 
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Under Pressure: How To Safeguard The EU Responsible Person

 
• By Amanda Maxwell

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