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

TEAM-NB Survey Shows Slow But Promising Progress Towards MDR/IVDR Certification

 
• By Amanda Maxwell

Manufacturers are creating their own delays by failing to submit the correct technical documentation to notified bodies. Nevertheless, the latest Medical Device Regulation amendment looks set to ensure compliance against new deadlines is tenable, a recent survey shows.

Meeting Target
• Source: Shutterstock

The EU medtech sector still faces challenges when it comes to organization of its resources and the need to move swiftly; but the EU notified body industry association, TEAM-NB, believes “complete numbers” of products being in conformity with the new Medical Device and IVD Regulations by the new deadlines are achievable.

According to its latest survey, they are only attainable, however, if manufacturers proceed now with their applications to ensure...

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

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

More from Geography

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 
• By Natasha Barrow

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.