Stay informed on the latest updates in medical device regulatory affairs to enter regulated markets fully prepared.
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 May 5, 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with accompanying
Team-NB, the European Association of Medical Devices Notified Bodies, has published Version 3 of its “Best Practice Guidance for the
Team-NB, the European Association for Medical Devices of Notified Bodies, has released an updated position paper addressing the implementation and
The International Organization for Standardization (ISO) is preparing a revision of ISO 10993-1, the critical standard governing the biological evaluation
The European Health Data Space (EHDS) Regulation was published in the Official Journal of the European Union on 5 March
South Korea’s Ministry of Food and Drug Safety (MFDS) announced on January 24th that it has released the first-ever guidelines
In a move that has taken many in the technology and legal sectors by surprise, the European Commission has withdrawn
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