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Regulatory Affairs Newsletter Archive

MHRA trials five innovative AI technologies as part of AI Airlock pilot Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA trials five innovative AI technologies as part of AI Airlock pilot

Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock, a pilot scheme to better understand how to regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible. These…
Ben Kemp
December 9, 2024
2025 BIVDA Regulatory Affairs Seminar agenda released BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

2025 BIVDA Regulatory Affairs Seminar agenda released

The agenda for BIVDA’s 2025 Regulatory Affairs Seminar in Birmingham on February 11 - 12 2025 has now been released. Expert figures in diagnostics regulation including David Lawson, Director of Medical Technology, Department of Health and Social Care; Robyn Meurant, Principal Consultant, ACT-IVD; and Megha Deviprasad Iyer, Director of Global Strategic Regulatory Affairs, Thermo Fisher, will lead sessions designed to…
Ben Kemp
December 9, 2024
MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 16 Dec 2024 3-4 pm CET) MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 16 Dec 2024 3-4 pm CET)

On Monday, 16 December 2024 at 15:00 – 16:00 pm CET (Brussels time), MedTech Europe will host its next quarterly webinar regarding the implementation status of the EU in vitro Diagnostic Medical Devices and Medical Devices Regulations (IVDR and MDR) for its partner medtech trade associations around the world. The webinar will be 60 minutes in duration including a 30-minute…
Ben Kemp
December 5, 2024
MHRA Updates (WC 2 Dec) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 2 Dec)

Complaints procedure Page summary: How to make a complaint about a service provided by the Medicines and Healthcare products Regulatory Agency. Change made: Updated to add additional complaints procedure guidelines Time updated: 10:08am, 25 November 2024
Ben Kemp
December 5, 2024
Department of Health and Social Care Updates (WC 2 Dec) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 2 Dec)

Folic acid supplementation: advice to health professionals Page summary: The UK chief medical officers, chief nursing officers and chief midwifery officers have given advice on the importance of folic acid supplementation. Change made: First published. Time updated: 12:16pm, 27 November 2024 First patients benefit from cutting-edge UK scanner to transform drug discovery and diagnose serious illnesses earlier Page summary: New…
Ben Kemp
December 5, 2024
DSIT Updates (WC 2 Dec) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 2 Dec)

Landmark genetics partnership to probe causes of cancer and dementia Page summary: Oxford Nanopore’s breakthrough genetic sequencing tech to analyse 50,000 samples from UK Biobank, to create a world-first ‘epigenetic map’. Change made: First published. Time updated: 7:00am, 27 November 2024 First patients benefit from cutting-edge UK scanner to transform drug discovery and diagnose serious illnesses earlier Page summary: New…
Ben Kemp
December 5, 2024
Office for Product Safety and Standards Updates (WC 2 Dec) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Updates (WC 2 Dec)

Use of metal and non-metal nanomaterials in consumer products Page summary: The use of metal and non-metal nanomaterials in consumer products and associated safety issues. Change made: First published. Time updated: 12:33pm, 25 November 2024 Regulations: ecodesign of energy-consuming products Page summary: Guidance for manufacturers, their authorised representatives and importers. Change made: Attachment Legislation List Updated. Time updated: 10:04am, 28…
Ben Kemp
December 5, 2024
Brexit Updates (WC 2 Dec) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 2 Dec)

Search the register of customs agents and express operators Page summary: Find a customs agent or express operator to help you with import and export declarations. Change made: The list of customs agents has been updated with 16 additions, 2 amendments and 1 removal.The list of express operators has been updated with 1 addition and one amendment. Time updated: 3:36pm,…
Ben Kemp
December 5, 2024