March 23, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
MDSAP Auditing Approach P0002.010 2026/02/06
Dear Members, MDSAP Auditing Approach updated to P0002.010 20260206 can be found here.
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March 23, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
NIST Report AI 800-4 Challenges to the monitoring of deployed AI
Dear Members, NIST have published a new report AI 800-4 on the challenges of monitoring deployed AI New Report: Challenges to the Monitoring of Deployed AI Systems | NIST
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March 19, 2026 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
EN ISO/IEC 42001:2026
Dear Members, please be advised that the following standards has been adopted by CEN/CENELC as an EU standard. It will also be adopted as a British Standard. This is separate from any future harmonisation to the EU MDR/IVDR. EN ISO/IEC 42001:2026 - Information technology - Artificial intelligence - Management system (ISO/IEC 42001:2023) (publication date=2026-03-18) View article...
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March 19, 2026 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
TEAM-NB IVDR Technical Documentation training for Manufacturers
Team NB are running a training course on EU IVDR Technical Documentation requirements for manufacturers. See below and attached IVDR Technical Documentation Training for Manufacturers On Thursday, 2026, July 2nd 9:00-17:00 CET (remotely) To register fill the form at the address: https://www.team-nb.org/manufacturertraining/ Link also available in NEWS: https://www.team-nb.org/new-session-ivdr-technical-documentation-training-for-manufacturers/
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March 19, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Therapeutic Goods (Information Specification – Database of Recalls, Product Alerts and Product Corrections) Instrument 2025
Dear Members, TGA have updated their information specification for their recalls and product alerts and corrections database. Therapeutic Goods (Information Specification – Database of Recalls, Product Alerts and Product Corrections) Instrument 2025 This Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the Database of Recalls, Product Alerts and Product Corrections…
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