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New IVDR Notified Body Named After A Nine-Month Gap

 
• By Amanda Maxwell

A new EU notified body has been designated under the IVD Regulation after nine months of an absence of news; but another hiatus is likely now until October.

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At last, with just over three weeks to go until the EU’s IVD Regulation fully applies, a new notified body has been appointed – some nine months after the previous one to be designated under the IVDR.

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More from Europe

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.

Unlocking Potential: Could EU’s New Surgical Centers Drive Demand For Advanced Medtech?

 
• By Amanda Maxwell

Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.

More from Geography

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

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.

Indian Medtechs Call US Tariffs A Challenge To Growth And Seek Reciprocal Regulatory Access

 
• By Shubham Singh

India’s medical technology industry is raising the alarm over steep new US tariffs on imported medical devices. It argues for structural change to address “unequal regulatory access” and non-tariff barriers.