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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
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

AMDEA Monthly Newsletter

Please see the newsletter from AMDEA and note the comments regarding the Product Regulation and Metrology Bill (IVD’s maybe in scope, and many off the shelf accessories used with IVDs will definitely be in scope). Lithium batteries is one such device that will be in scope, but which is not specifically identified in the present legislation framework. Note also the…
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