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“Decisive And Rapid” Action Needed On UK Regulations As Target Dates Looking Unlikely

 
• By Amanda Maxwell

The UK is in political and economic turmoil. There has been an exodus of staff at the UK’s medtech regulatory agency, the MHRA. And now it is looking as if the supposed post-Brexit opportunities to legislate medtech creatively may be lost. 

Compass
Has The UK Lost Its Regulatory Compass? • Source: Alamy

“Urgent action on completing the necessary legislative processes” for the regulation of medtech products is needed in the UK, Peter Ellingworth, chief executive of the Association of British HealthTech Industries (ABHI), has said.

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Italy’s IMQ Designated As 15th Notified Body For IVDs

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

More from Geography

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Looking Back Towards The Future

 
• By Brian Bossetta

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.