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MHRA Sets Out Summer Schedule Of Medtech Regulatory Milestones

Regulator and law firm broach new methods for lifecycle management of AI/ML devices

 
• By Ashley Yeo

UK devices regulator signals near-term progress on PMS statutory instrument, policy statement on international recognition and input into IMDRF project to update  global diagnostics guidance.

AI Regulation
• Source: Shutterstock

Fresh back from the 25th session of the International Medical Device Regulators Forum (IMDRF) in March, the UK Medicines and Healthcare products Regulatory Agency hit the ground running in April to progress its ambitious regulatory system plans for Great Britain.

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More from United Kingdom

Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 
• By Natasha Barrow

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
• By Ashley Yeo

The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

UK Treading A Tightrope On Trump’s Tariffs

 
• By Ashley Yeo

Medtech has not yet been spared from the Trump administration’s trade tariffs, which, for UK exporters will be 10% – half the rate applied to EU27 exporters.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 
• By Natasha Barrow

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

More from Europe

Commission Needs To Prioritize Devices Agency Above All Else

 
• By Amanda Maxwell

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
• By Ashley Yeo

The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.