Your leading voice in digital health news
Twitter X Logo

EU delays high-risk medical device AI rules

13 August 2026
By Reesh Lyon
Developers of AI-enabled medical devices in Europe have been given an additional two years to meet high-risk requirements under the EU AI Act, following the entry into force of the European Union’s AI Omnibus. The changes delay the application of high-risk AI requirements for systems embedded in regulated physical products, including medical devices, to 2 […]

Subscribe to read more

Pulse+IT website access

Keep your finger on the pulse with full access to all articles published on pulseit.news
Instant access
All articles
Cancel anytime

Your leading voice in digital health news

Twitter X

Your leading voice in digital health news 

Keep your finger on the pulse with full access to all articles published on 
pulseit.news
Subscribe from only $39
magnifiercrossmenuchevron-down