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Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterRegulatory Affairs Newsletter

EU / UK regulation updates – Other legislation

The EU have recast the Liability for defective products directive (EU) 2024/2853, which comes into force 8th December 2024 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024L2853 Note that the maximum timeframe for entitlement for compensation is normally 10 years, but can be up to 25 years (Article 17) – this could impact minimum document retention periods. Additionally, the Recast EU General Safety and Performance Regulation 2023/1828…
Ben Kemp
December 5, 2024
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New legislation and amendments to adapt the EU single market in the event of a crisis

The EC have published new legislation to adapt the EU single market in the event of a crisis. It allows for flexibility in continuing to be able to place products on the market under emergency conditions. Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal…
Ben Kemp
December 5, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Clinical Trials Guidance

MHRA’s Mark Grumbridge, earlier this month sent out a reminder on LinkedIn about their Clinical Investigation Guidance Page Clinical investigations guidance - GOV.UK which includes links to a useful checklist and updated information on conducting trials in Northern Ireland.
Ben Kemp
December 5, 2024
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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
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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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