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MHRA announce new Chair

Anthony Harnden has been appointed as the new chair of the Medicine and Healthcare products Regulatory Agency (MHRA). Anthony is a Professor of Primary Care at the University of Oxford, and until the end of December 2024, a registrant Council member of the General Medical Council and Chair of the Renumeration Committee. He worked for the NHS for 40 years…
Ben Kemp
November 20, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA consultation on Medical Devices Regulations for routes to market and IVDs

The MHRA last week opened their consultation on Medical Devices Regulations for routes to market and in vitro diagnostic devices. This relates to the proposed pre-market Statutory Instrument which is planned to be laid before parliament next year. The MHRA are seeking views as a number of changes have occurred since they previously consulted last year. Areas are: -     International…
Ben Kemp
November 19, 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 11 Nov)

Smarter regulation: UK product safety review Page summary: We’re inviting views on the long-term approach to product safety, and how to ensure that the regulatory framework is fit for the future. Change made: Government response published. Time updated: 9:55am, 5 November 2024
Ben Kemp
November 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 11 Nov)

Trade and Cooperation Agreement Partnership Council Decision number 1 for 2024: updates to product specific rules Page summary: Information on the Partnership Council’s first decision in 2024 on updates to a number of Product Specific Rules in the Rules of Origin annexes of the TCA. Change made: First published. Time updated: 11:00am, 6 November 2024 Trade and Cooperation Agreement Governance…
Ben Kemp
November 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 11 November)

Labour Market Enforcement Strategy 2025 to 2026: call for evidence Page summary: Call for evidence from Margaret Beels, the Director of Labour Market Enforcement, to inform her labour market enforcement strategy for 2025 to 2026. Change made: First published. Time updated: 9:00am, 4 November 2024 Making Work Pay: creating a modern framework for industrial relations Page summary: We are consulting…
Ben Kemp
November 14, 2024
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Latest Laura Squire MHRA Blog

Please find the latest Laura Squire blog from MHRA here. BIVDA continue to be actively involved as trusted advisors, participating on behalf of members in the ongoing consultations. MHRA continue to firm up it’s position head of publishing the amendments to the UK MDR legislation.
Ben Kemp
November 6, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MedSafetyWeek 2025: Preventing side effects  – GOV.UK

Please see the MHRA campaign to increase reporting of 'Side effects' including from devices: https://www.gov.uk/government/news/medsafetyweek-2025-preventing-side-effects?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=fe0d651f-079a-4edb-903f-95cffc124c1d&utm_content=immediately
Ben Kemp
November 6, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 4 Nov)

New UK-EU Competition Cooperation Agreement Page summary: UK Government and the European Union have formally concluded negotiations on the UK-EU Competition Cooperation Agreement. Change made: First published. Time updated: 10:45am, 29 October 2024 Transit newsletters – HMRC updates Page summary: Check for the latest updates about moving goods using transit and the New Computerised Transit System (NCTS). Change made: Newsletter…
Ben Kemp
November 6, 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 4 Nov)

Domestic Advisory Group (DAG): call for expressions of interest Page summary: DBT invites expressions of interest from organisations to become members of the DAG to support the implementation of free trade agreements. Change made: Closing date changed from 12:00pm on 31 October 2024 to 12:00pm on 14 November 2024. Time updated: 4:57pm, 28 October 2024 New UK-EU Competition Cooperation Agreement…
Ben Kemp
November 6, 2024