Ursula Von Der Leyen Calls For EU Medtech Regulatory Framework To Be 'Stepped Up'

A European Cybersecurity Action Plan For Hospitals Is Also On The Cards

The commission's recently reelected president also wants the new commission to evaluate the need for potential changes to the medtech regulations.

Ursula von der Leyen at lectern in front of EU flag
Ursula Von Der Leyen Has Selected Her Commissioners Designate • Source: Shutterstock

The good news is that the availability and competitiveness of medical devices are due to feature high on the European Commission’s agenda over the coming years.

This is one of the priorities that commission president, Ursula von der Leyen, has listed for Olivér Várhelyi, Commissioner-designate for...

More from Europe

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

More from Geography

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

Commission Decision Launches Pediatric And Rare Disease Expert Group

 

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.