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Regulatory Affairs Newsletter

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APHA Updates (WC 26 Aug)

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 licences:- General licence to import certain products for in vitro use with 10% or less animal by-product carrier or stabilizer…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Weekly Update (WC 26 Aug)

Overseas business risk: Honduras Page summary: The overseas business risk report provides information on security and political risks UK businesses may face when operating in Honduras. Change made: The guidance has been reviewed and updated where necessary, Time updated: 1:32pm, 19 August 2024 Overseas business risk for Guatemala Page summary: The overseas business risk report provides information on security and…
Ben Kemp
August 27, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Proposed Common Specifications update

Please see the proposed update and introduction of new Common Specifications for Class D devices under the EU IVD Regulation. Please let us know if you have any feedback on the proposals. Note that the consultation close 16th September, so BIVDA will require feedback by Close of Business 13th September. Remember that these will apply in Northern Ireland, and MHRA…
Ben Kemp
August 27, 2024
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2024 Global Outlook for chemicals & chemical products: Mid-year review for the Americas

During this one-hour webinar, expert analysts will share insights on recently amended regulatory developments across the Americas in 2024 so far, plus look at what’s coming up. Join on Wednesday 4 September by clicking here. 
Ben Kemp
August 27, 2024
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Common specifications for IVDs for parasites, viruses proposed by European Commission

The European Commission has suggested revising the common specifications for certain class D in vitro diagnostic devices to address tests for specific parasites and viruses of public health importance. Stakeholders have a four-week period to provide feedback on these proposed changes. On 19 August, the Commission released the proposed amendments, which, if approved, would update the In Vitro Diagnostic Medical…
Ben Kemp
August 27, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA AI Airlock Webinar from July 2024 available

The MHRA have uploaded their webinar covering the AI Airlock from July, which may be of interest to members. The webinar provides a helpful overview of the utilisation of the Airlock for the development of AI IVDs. It can be accessed here.
Ben Kemp
August 23, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 19 August)

Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: References to Customs Handling of Import and Export Freight (CHIEF) system have been removed as all import and export declarations must now be made through the Customs Declaration Service. Time updated: 3:40pm,…
Ben Kemp
August 21, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 19 August)

AI Upskilling fund Page summary: The AI Upskilling fund pilot scheme will support small and medium-sized enterprises (SMEs) by match-funding AI skills training for their employees. Change made: Added details of a drop-in webinar on Wednesday 14 August 2024. Time updated: 3:32pm, 12 August 2024 Cyber Essentials management information Page summary: Figures showing the number of Cyber Essentials certificates awarded,…
Ben Kemp
August 21, 2024
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