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UK Medtech's Gateway To Regulatory Opportunity Is Open – But For How Long?

MHRA issues guidance on GB standstill extension and EU MDR/IVDR transitions aide-memoire

 
• By Ashley Yeo

The pace of activity in medtech circles as the UK government and MHRA target a robust-but-agile regulatory system for Great Britain has been fairly relentless. Manufacturers serving the British medtech markets eye the plans and promises with patience – for now at least.  

Regulations
• Source: Shutterstock: Yu Ping Chen

The pace of activity aimed at creating a sovereign UK medtech regulatory system remains high, even after the flurry of policy announcements in late May. And as it gets deeper into the task, the Medicines and Healthcare products Regulatory Agency (MHRA) is aware that it retains the support of the UK industry. (Also see "UK Pro-Innovation Report Offers Promise For Medtech With MHRA/NICE Alignment" - Medtech Insight, 30 May, 2023.)

In mid-June, the UK government issued amended legislation to implement the extension of the periods during which certain EU-approved devices...

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