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How do AI regulations effect medical device development?

Understand the impact of AI and emerging regulations on medical device development Thursday, December 12, 2024 | 09:00 AM (CST) - 10:00 AM (CST) Artificial intelligence (AI) is poised to transform medical engineering, but regulatory frameworks significantly impact its deployment in the healthcare industry. Join our webinar on Dec. 12, 2024, to deepen your understanding of the impact of AI…
Ben Kemp
December 4, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

QARAD: What’s the latest in the field of In Vitro Diagnostics?

Be ready to tackle the challenges of clinical performance studies under the IVDR 5 December 2024 | 16:00 CET Are you in full preparation for a new IVD submission or looking to refine your current approach? Then our upcoming webinar ‘Mastering Clinical Performance Studies under IVDR’ will provide actionable guidance to help you succeed. Our IVD experts will delve into…
Ben Kemp
December 4, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 25 Nov)

Register to use the Import Control System 2 Page summary: Use this system if you’re moving goods into Northern Ireland from Great Britain, or into Northern Ireland from outside the EU, and need to make an entry summary declaration. Change made: First published. Time updated: 10:00am, 20 November 2024 Make an entry summary declaration using the Import Control System 2…
Ben Kemp
November 27, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 25 Nov)

Prime Minister announces relaunch of UK-India free trade talks Page summary: The Prime Minister has announced that UK-India trade talks will relaunch in the new year. Change made: First published. Time updated: 10:45pm, 18 November 2024 UK-Côte d’Ivoire Stepping Stone Economic Partnership Agreement Committee – communique, 27 June 2023 Page summary: Communique following the second meeting of the UK-Côte d’Ivoire…
Ben Kemp
November 27, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 25 Nov)

Middlesbrough kicks off national roadshow of NHS debates Page summary: The national conversation about the NHS’s future took to the road, as Middlesbrough hosted the first of a series of public debates about fixing the NHS. Change made: First published. Time updated: 7:27pm, 16 November 2024 Change NHS: help build a health service fit for the future Page summary: The…
Ben Kemp
November 27, 2024
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Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Text with EEA relevance)

Dear members, please see here the recast of the EU Liability for defective products directive – 2024/2853. Please note that IVDs are in scope as is software (except software which is provided free or open source, or provided outside of commercial activity). The directive applies from 9th Dec 2026. (Directive (EU) 2024/2853 of the European Parliament and of the Council…
Ben Kemp
November 26, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 18 Nov)

Zero tolerance for failure under package of tough NHS reforms Page summary: Health and Social Care Secretary will outline how government and NHS leaders have a duty to patients and taxpayers to get the system working well Change made: First published. Time updated: 12:01am, 13 November 2024 Our ambition to reform the NHS Page summary: The Health and Social Care…
Ben Kemp
November 26, 2024