1. Medtech Insight
  2. >>Geography
  3. >>Europe

Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50

 
• By Amanda Maxwell

Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.

AUDIT word written on wood block

EU notified body numbers and capacity for medical device auditing is looking healthy as the region is now approaching the same number of notified bodies under its Medical Device Regulation as it had in 2017 under the former Medical Devices Directive.

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
Start Free Trial

Already a subscriber?

More from Europe

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.

Anglonordic 25: Pictura Bio’s One-Minute Pathogen-Identifying Diagnostic Test

 
• By Natasha Barrow

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
• By Ashley Yeo

Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.

More from Geography

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

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.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025