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Regulatory Affairs Newsletter

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The Research and Development Relief (Information Requirements etc.) Regulations 2024

These Regulations amend the Relief for Research and Development (Content of Claim Notifications, Additional Information Requirements and Miscellaneous Amendments) Regulations 2023 to restate the information that has to be provided by a company claiming relief from corporation tax in respect of expenditure on research and development (“R&D”). The changes they make reflect significant reforms to the R&D regime made by…
Ben Kemp
September 17, 2024
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2025 Regulatory Affairs Seminar

The Regulatory Affairs Seminar will be held on the 11th and 12 February 2025. BIVDA’s Regulatory Affairs Seminar brings together the UK’s leading regulatory specialists to learn and collaborate.  Next year’s event is being held at the Grand Hotel, Birmingham. Tickets are available at £895 per ticket, the event is currently NOT on Eventbrite so please signal your interest by…
Ben Kemp
September 17, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860

Dear Members, MedTech Europe have drafted a manufacturers declaration to Regulation (EU) 2024/1860, the latest IVD regulation transitional legislation. The declaration can be used to support the continued use of IVD Directive Certificates that have expired, but where the manufacturer continues to meet the requirements of the updated legislation and Article 110 of the IVD Regulation 2017/746. To: Regulatory Affairs…
Ben Kemp
September 11, 2024
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BSI AI algorithm auditing and dataset testing

In preparation for incoming AI legislation, BSI has proactively developed an Algorithm Auditing and Dataset Testing service to help organizations prepare for success. An Algorithm Auditing & Dataset Testing confirmation letter from BSI demonstrates to customers, regulators, and other stakeholders that your algorithm performance claims have been verified by an impartial and independent third party. Establish trust and credibility in…
Ben Kemp
September 11, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft Scottish National Adaptation Plan 3 (SNAP3) 2024-29 – consultation analysis

The below draft response from Scottish Government, maybe of interest to Scottish based members. As climate change impact increase, we will increasing need to adapt businesses to cope with the impacts. We’re already seeing climate change being a focus of business insurance, and access to finance, both in terms of business risk including supply chain risk. We’re seeing the need…
Ben Kemp
September 11, 2024
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