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How To Read The UK’s New Medical Device Regulations: MHRA Explains The Main Points

 
• By Amanda Maxwell

The UK’s 2019 medtech regulations laid in Parliament last week in preparation for a possible no-deal Brexit at the end of March are long and difficult to read. Medtech Insight spoke to the Medicines and Healthcare products Regulatory Agency to find out the essentials.

Aerial view of Westminster bridge and parliament buildings, London, UK
New UK medtech regulations were submitted to Parliament in preparation for a no-deal Brexit.

Brexit day comes in less than two months and the UK is hoping that its Parliament will soon adopt new regulations that amend its 2002 Medical Device Regulations to enable UK medtech rules to fully function in a no-deal Brexit scenario. The approach would includ mirroring the EU Medical Device Regulation (MDR) and IVD Regulation (IVDR) in UK law.

But the 224-page document is a complex read and time is short before a possible no-deal Brexit comes into force on March 29, 2019. The text contains an introductory...

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