May 12, 2026 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BIVDA Survey: provide views on medical devices regulations
DHSC has launched a request for stakeholder input as part of its statutory report under the Medicines and Medical Devices Act 2021. This report assesses how the regulations made under the Act are operating in practice. BIVDA has been invited to coordinate a sector response, and the UKCA Subgroup will be used to collate industry views where possible. We are…
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May 12, 2026 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA publishes draft Pre-Market Statutory Instrument and seeks views via survey
BIVDA broadly welcomes the publication of the draft Pre-Market Statutory Instrument on the WTO website by the MHRA. This draft SI provides an important indication of the future direction of the UK Medical Devices Regulations and demonstrates continued progress towards greater international harmonisation. We recognise the significant effort that has gone into reaching this stage and welcome the collaborative and…
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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
Takeaways from AI Impact Summit & The Philippines Join Global Regulatory Network
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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