EU AI Act Raises New Compliance Hurdles for Medical Devices
July 7, 2025
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
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
Team-NB, the European Association of Medical Devices Notified Bodies, has published Version 3 of its “Best Practice Guidance for the Submission of Technical Documentation under
Team-NB, the European Association for Medical Devices of Notified Bodies, has released an updated position paper addressing the implementation and application of the EU Artificial
The International Organization for Standardization (ISO) is preparing a revision of ISO 10993-1, the critical standard governing the biological evaluation of medical devices. This update
The European Health Data Space (EHDS) Regulation was published in the Official Journal of the European Union on 5 March 2025 and will enter into
South Korea’s Ministry of Food and Drug Safety (MFDS) announced on January 24th that it has released the first-ever guidelines for the approval and assessment
In a move that has taken many in the technology and legal sectors by surprise, the European Commission has withdrawn its proposed AI Liability Directive
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