Rebooting EU Medtech: Appetite For Urgent Discussions To Address Failing Regulations Grows

Lack of predictability uncertainty over fees and inefficient working practices inherent in the current implementation of EU rules are all demanding a rethink in the EU’s current and future medtech rules. Industry expects discussions to kick off early next year.

Fuzzy man walking on hanging bridge vanishing in fog. Focus on middle of bridge
Waiting For The Mists To Clear On Way Forward For EU's Medtech Regulation • Source: Shutterstock

Action is essential, both mid-term and more immediately, to improve the implementation of the EU’s medtech regulations and to find a better way forward as the “EU is not where it should be.”

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 

Ireland’s NSAI reinstated under IVD Regulation designation list

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

 

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 

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

 

“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

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By 

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

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

 
• By 

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 

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.