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BioTalk

10/27/2025 11:54:53 AM

Navigating the interplay of MDR and AIA: New MDCG Guidance on Medical Device AI Under the EU AI Act: EU and UK perspectives

By Pieter Erasmus Maud van Haaren Hester Borgers

The EU regulatory landscape for medical devices making use of artificial intelligence (MDAI) has become significantly more complex with...

10/23/2025 2:26:26 PM

By Sally Shorthose Pieter Erasmus Charlotte Getz

The UK has become the first country in the world to introduce a dedicated legal framework for the point of care (‘PoC’) and modular...