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The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning
Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a
Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are
The new EU Artificial Intelligence Act (AI Act, 2024/1689) adds a layer of regulatory requirements for medical device firms already
On June 13, 2025, the U.S. Food and Drug Administration (FDA) issued a pivotal final rule reclassifying radiological computer-assisted detection
On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the
A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional
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