Takeaways from the AI Impact Summit 2026 and HealthAI Welcomes Newest Global Regulatory Network Member News from Manila and Notes from New Delhi: Towards a bolder, more inclusive future Last month in New Delhi, I had the opportunity to attend the AI Impact Summit 2026, a milestone moment not only for global AI governance but also for the future…
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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
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 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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March 19, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
HRA Now – Study set-up at site survey 2026
Dear Members, please see below UK HRA update - UKHRA survey and upcoming revised research agreements.
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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
TGA Software based medical device exclusion guidance
Dear Members, TGA has posted Guidance on Software based medical device exclusions for specific uses. Software-based medical device exclusions | Therapeutic Goods Administration (TGA) TGA – Guidance - Understanding the health facility management software exclusion - Guidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements. View article...…
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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
The Digital Markets, Competition and Consumers Act 2024 (Commencement No. 3 and Transitional Provisions) Regulations 2026
Dear members, the implementation legislation below impacts the provision of alternative dispute resolution under the Digital Markets and Competition and Consumer Protection Act 2024. The Digital Markets, Competition and Consumers Act 2024 (Commencement No. 3 and Transitional Provisions) Regulations 2026 These Regulations bring into force Chapter 4 of Part 4 and Schedules 25 to 27 of the Digital Markets, Competition…
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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
Commissioner Várhelyi to open high-level event on medical devices
Commissioner Várhelyi to open high-level event on medical devices Next Monday 16 March, EU Commissioner for Health and Animal Welfare Olivér Várhelyi will open a high-level conference in Brussels on “Medical Devices: Innovation and Patient Safety”. The event, hosted by the Commission under the auspices of the Cypriot Presidency of the Council, will bring together a wide range of industry,…
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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
TGA Guidance – Understanding your post-market responsibilities for medical devices
TGA Guidance - Understanding your post-market responsibilities for medical devices - Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. View article...
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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
EN IEC 60445:2021/A1:2026 – Basic and safety principles for man-machine interface, marking and identification – Identification of equipment terminals, conductor terminations and
Updated electrical safety standard EN IEC 60445:2021/A1:2026 - Basic and safety principles for man-machine interface, marking and identification - Identification of equipment terminals, conductor terminations and conductors (publication date=2026-03-13) View article...
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March 13, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
TGA – Understanding how we regulate software-based medical devices
Dear Members, TGA Australia have updated guidance on Understanding how we regulate software-based medical devices Guidance on how we regulate software-based medical devices. View article...
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March 13, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
The Digital Markets, Competition and Consumers Act 2024 (Alternative Dispute Resolution) (Conferral of Functions) Regulations 2026
The Digital Markets, Competition and Consumers Act 2024 (Alternative Dispute Resolution) (Conferral of Functions) Regulations 2026 These Regulations confer functions on the Chartered Trading Standards Institute (“the CTSI”) in relation to alternative dispute resolution for consumer contract disputes under the Digital Markets, Competition and Consumers Act 2024 (c. 13) (“the Act”), and make provisions in connection with the conferral of…
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March 13, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
One IPO update – changes to patent paper forms
One IPO update - changes to patent paper forms We’re continuing our work to modernise and simplify the way customers interact with the Intellectual Property Office as we prepare for the launch of our new One IPO Patent Service. The latest blog in our What’s changing series looks at how patent paper forms are changing, and what this means…
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March 13, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
HRA Now – New process to make it easier to set up research involving health and social care staff as participants
What: we are introducing a new proportionate process to make it easier to set up research involving health and social care staff as participants in the UK Who: sponsors, researchers, NHS and HSC organisations in England, Wales, Scotland and Northern Ireland When: the new process comes into effect on Tuesday 10 March 2026 We are introducing a new process to help streamline the application…
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March 9, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
The Medical Devices (Fees Amendment) Regulations 2026
Dear members, as previously discussed regarding the changes to the MHRA fees, the proposal has now been adopted in law, amending the UK MDR 2002 (as amended) and the Medical Device (Northern Ireland Protocol) Regulations 2021 The Medical Devices (Fees Amendment) Regulations 2026 These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”) and the Medical Devices…
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March 9, 2026 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
IMDRF – Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation
Dear Members, please be advised that IMDRF have published their consultation on Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation. View article...
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