
When AI Systems Meet Medical Devices
AI is changing healthcare. It can detect patterns in images, predict patient deterioration, prioritise care pathways and automate routine decisions. But when AI performs or
AI is changing healthcare. It can detect patterns in images, predict patient deterioration, prioritise care pathways and automate routine decisions. But when AI performs or
The EU’s Artificial Intelligence Act (Regulation (EU) 2024/1689) imposes comprehensive transparency and safety duties on providers of general-purpose AI (GPAI) models. A special focus hereby
The EU’s still somewhat new AI Act (Regulation 2024/1689) introduces a sweeping compliance regime, but its requirements come into force in phases. In particular, the
Artificial intelligence is transforming the medical device sector by powering diagnostic tools, guiding robotic surgeries, and delivering personalised treatment recommendations. However, innovation is outpacing regulation.
As the global AI market booms, many startups and SaaS companies are eager to claim the label of “AI company.” Yet, beneath the buzzwords, a
On 10 July 2025, the European Commission unveiled the General-Purpose AI (GPAI) Code of Practice. Crafted by an independent expert group under the guidance of
Welcome to Part 4 of our blog series ‘Decoding the EU AI Act’! Central to the legislation is Article 5, which identifies and prohibits certain