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

EU AI Act Legal Deep-Dive Part 2: Balancing Medtech Innovation With Safety

 
• By Eliza Slawther

The EU AI Act could introduce rigorous regulatory requirements for AI-based medical devices in addition to those contained in the MDR/IVDR. Lawyers from Cooley LLP tell Medtech Insight how changes to the commission’s proposal could improve its impact on medtech while keeping patients safe.

AI Legislation
• Source: Shutterstock

Tomorrow (14 June), the European Commission’s landmark AI Act proposal is scheduled to undergo a plenary vote by members of the European Parliament, which could see the draft text move into the final high-level negotiation phase, known as trilogue discussions.

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

EU Harmonized Standards Continue To Trickle In Under MDR

 
• By Amanda Maxwell

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By Ashley Yeo

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.

Commission Needs To Prioritize Devices Agency Above All Else

 
• By Amanda Maxwell

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
• By Ashley Yeo

The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

More from Geography

Biotech Leader Predicts Delays On Device Approvals As FDA Makes Life-Saving Drugs Sole Priority

 
• By Natasha Barrow

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By Elizabeth Orr

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.