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If You Build It, Will They Come? Vital That UK MHRA Creates Right Environment For Medtechs

Pragmatism urged as UK devices regulator decides how much or how little to regulate

 
• By Ashley Yeo

The Medicines and Medical Devices Act presses the UK to regulate in such a way that makes the market attractive for industry and investment. Medtech manufacturers insist the MHRA must strike the right balance as it brings its ‘plan for a new agency’ to life, said the ABHI’s Phil Brown, in the second of a two-part industry view of UK medtech’s regulatory future.

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In the post-Brexit discussions on the UK's future medical devices regulatory instrument, two opposing views have emerged. One is that, given its sophisticated health care system, the UK will need its own processes of regulatory approval, and enough qualified staff to take care of those needs.

The other suggests the regulator should pursue merely a registration scheme for medtech products that it recognizes from international markets,...

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