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Prepare for ISO 42001 webinar

There's still time to register for our upcoming webinar: Prepare for ISO 42001 – a framework for the management of AI. In this session we will discuss how organizations can proactively prepare for upcoming AI regulations by implementing the right processes and controls. This webinar is ideally suited for professionals across a wide range of industries that are looking to…
Ben Kemp
October 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Medicines and Healthcare products Regulatory Agency Update (WC 13 Oct)

MHRA Corporate Plan: 2023 to 2026 and Business Plan: 2023 to 2024 Page summary: These reports outline the MHRA’s Corporate and Business Plans, detailing the agency’s strategic direction over the next three years. Change made: Published MHRA Business Plan: 2024 to 2025 Time updated: 3:32pm, 7 October 2024 MHRA launches 2024/25 business plan with focus on enabling access to groundbreaking…
Ben Kemp
October 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 13 Oct)

Standardisation Page summary: Standardisation explained. Change made: New Memorandum of Understanding between DBT and BSI added. Time updated: 10:08am, 7 October 2024 Common charger for electrical devices: call for evidence Page summary: We are inviting views on the introduction across the UK of a common charger for mobile phones and other portable electrical and electronic devices. Change made: First published.…
Ben Kemp
October 16, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Update (WC 13 Oct)

Standardisation Page summary: Standardisation explained. Change made: New Memorandum of Understanding between DBT and BSI added. Time updated: 10:08am, 7 October 2024 End-user undertaking (EUU) form Page summary: End-user undertaking form which must be completed to comply with standard individual export licence (SIEL) and standard individual trade control licence (SITCL) terms and conditions. Change made: End user undertaking form has…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Update (WC 13 Oct)

New Government tech deals boost the business of cancer detection Page summary: New UK-created therapies for cancer will be trialled in the UK – furthering the nation’s life sciences industry as one of the great drivers of economic growth. Change made: First published. Time updated: 12:01am, 6 October 2024 Engineering Biology Sandbox Fund: successful projects Page summary: This fund supports…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 13 Oct)

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: The waiver for import requirements for goods from the EU (and other territories that did not have requirements before 1 January 2021) has been extended until 31 January 2025. Time updated: 9:06am,…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Stay Compliant with New IVD Regulations

Wednesday, Oct,16th , 2024 | 9:00 AM – 9:45 AM (Austin Texas, U.S.) Join Heather Crawford from the Emergo by UL’s team, live on Oct. 16, 2024 from 9-9:45 a.m. CST as she discusses Regulation (EU) 2024/1860. What has changed with the adoption of Regulation (EU) 2024/1860, and how can you determine whether you are eligible for the extension under…
Ben Kemp
October 15, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2024

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2024 (legislation.gov.uk) The Windsor Framework requires that the European Union (“EU”) legislation listed in its Annex 2 is implemented in Northern Ireland. One of the Directives listed in Annex 2 is Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to…
Ben Kemp
October 15, 2024
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Brazil IVD News: Regulation updates

To help you navigate the Brazilian Health Regulatory Agency's (ANVISA) latest updates for in vitro diagnostics (IVDs) and the implications for your healthcare products, we highly recommend you review this detailed report by Patricia Urakawa, Senior Consultant of Regulatory Affairs at Emergo by UL. This invaluable resource explains several critical updates to RDC 830/2023 that you should be aware of,…
Ben Kemp
October 15, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32024D2657: Council Decision (EU) 2024/2657

Two new harmonised standards have been added for IVD under the EU IVD regulation. In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added: No ‘14. Reference of the standard EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) No ‘15. EN ISO 20916:2024 In vitro diagnostic medical devices –…
Ben Kemp
October 15, 2024
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