AI Act Is Officially Published: Implementation Challenges Ahead For Medtech

The final text of the AI Act is now available for all to read but, for medtech, it may feel that work is only just beginning.

airport runway under the sun as background
It's Take Off Time Now For The EU's AI Act

The text of the EU’s AI Act, which lays the foundation for responsible development of AI across all industrial sectors, was published in the Official Journal of the EU on 13 July and is due to enter into force on 2 August.

The deadline for the application of Regulation (EU) 2024/1689 to AI-enabled medical technologies already regulated under the Medical Device Regulation...

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

More from Europe

More from Geography

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By 

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.