All AI Medical Devices are High-Risk?
AI promises to enhance diagnostics, personalise treatments, and optimise resource allocation across the healthcare systems (Public Health). In recognition of its potential and risks, the EU adopted the Artificial Intelligence Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024 (team-nb). Unlike sector‑specific laws, it applies horizontally, using a risk‑based approach to regulate AI systems according to […]
UK Post-Market Surveillance Requirements: Act Before June 2025
The UK has just rolled out one of its most impactful regulatory changes since Brexit — a new set of post-market surveillance (PMS) requirements for medical devices. Here’s what manufacturers, UK Responsible Persons, and industry stakeholders need to know to stay compliant. What are the new UK PMS requirements for medical devices? n December 2024, […]