On 3 December 2025, the European Commission released a 12-page draft Implementing Regulation (Ares(2025)10569703) establishing detailed rules for the operation of AI regulatory sandboxes under
A new development in healthcare cybersecurity is the publication of IEC TS 81001-2-2:2025, which provides updated guidance on the implementation, disclosure, and communication of security
A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the European Commission to allow Authorised
Overview of the EU AI in Healthcare Study In August 2025, the European Commission released a final report on the deployment of AI in healthcare.
The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices and IVDs,
Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a new pathway for Class III
The new EU Artificial Intelligence Act (AI Act, 2024/1689) adds a layer of regulatory requirements for medical device firms already governed by the Medical Device
On June 13, 2025, the U.S. Food and Drug Administration (FDA) issued a pivotal final rule reclassifying radiological computer-assisted detection and diagnosis (CADe/CADx) software from
On May 5, 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with accompanying help text, XSD/XSL files, and
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