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Regulatory Affairs Newsletter Archive

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The Role of AI in the Practice of Human Factors Engineering

Wednesday, Nov, 20, 2024 | 9:00 AM - 10:00 AM CST Join subject matter experts, Michael Wiklund, Principal consultant, and Julee Henry, Lead human factors specialist from Emergo by UL’s Human Factors Research & Design team on Nov. 20th, 2024 from 9:00 – 10:00 AM CST for an insightful session on the role of AI in the practice of human…
Ben Kemp
November 14, 2024
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Successful Regulatory Strategy: Best Practices for the Diagnostic Sector

Our 2025 Regulatory Affairs Seminar is bringing together expert speakers to show how to develop a successful regulatory strategy; from bringing products to the market to navigating post-market surveillance. With confirmed speakers from BSI, MedTech Europe, TUV Sud, and the MHRA, the two-day event on 11th and 12th February 2025 is one not to be missed by regulatory specialists. BIVDA's…
Ben Kemp
November 13, 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
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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
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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
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