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Which Parts Of The EU AI Act Are Unsuitable For Medtech?

 
• By Eliza Slawther

Many computer science experts believe that the European Commission’s proposed AI Act is too legislatively heavy. In the second of a two-part interview series, Philips’ Koen Cobbaert explains what parts of the draft legislation are most troublesome for medtech.

AI Doctor
• Source: Shutterstock

Specific elements of the EU’s Artificial Intelligence (AI) Act, such as its data requirements, may result in less effective medtech products. Koen Cobbaert, senior manager, quality, standards, and regulations at Philips, reveals in the second part of a recent interview with Medtech Insight why updates to the draft AI Act text have not resolved hurdles for the medtech industry.

In the first of this two-part interview series, Cobbaert had explained what the latest developments and amendments made to the...

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More from Europe

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

 
• By Amanda Maxwell

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’

 
• By Natasha Barrow

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

 
• By Amanda Maxwell

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

 
• By Brian Bossetta

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

 
• By Amanda Maxwell

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

 
• By Brian Bossetta

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

 
• By Amanda Maxwell

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