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Regulatory Affairs Newsletter

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IP Connect: Exclusive insights from Washington talks and latest policy updates from the UK

London to host world's largest IP event in 2026 The UK's global leadership in IP has been recognised with the announcement that the International Trademark Association (INTA) will hold its 148th Annual Meeting in London from 2-6 May 2026. This prestigious event – the largest gathering of IP professionals and brand owners worldwide – is expected to attract more than…
Ben Kemp
June 9, 2025
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Update: culture media and antibodies subject to additional Border Inspection Post controls

Please see below update from Medtech Europe regarding the proposal to include new CN codes in the EU Animal By-products legislation. See also the EC response to the issues posed by MedTech Europe. Please note that these requirements will also impact shipments from GB to Northern Ireland, as well as shipments from third countries to Northern Ireland, and shipments from…
Ben Kemp
June 9, 2025
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APHA – Border Trade Newsletter – getting it right at the border 29-05-25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: Some of the messages in this edition were originally sent last week, However, they remain…
Ben Kemp
June 9, 2025
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MHRA Safety Roundup: May 2025

Note that MHRA have issued the below notice regarding Biotin Interference with Thyroid Function Tests (Immunoassays). FDA had previously issued guidance regarding this topic Testing for Biotin Interference in In Vitro Diagnostic Devices | FDA. Although MHRA have specifically highlighted the issue with TFT tests, manufacturers should consider Biotin interference with their Immunoassays more generally. MHRA have an ongoing consultation…
Ben Kemp
June 9, 2025
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FDA Consensus Standards

FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing   05/26/2025…
Ben Kemp
June 9, 2025
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FDA Guidance – June 2025

These are the updates published since 07/01/2025 (when we last put updates on regulatory newsletter) up to and Including 29/05/2025. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program | FDA Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff | FDA Data Standards Catalog | FDA…
Ben Kemp
June 9, 2025
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MHRA AI Airlock Webinar – 19th June

The MHRA will hold a webinar on 19th June at 10:00 - 11:30 to provide an update on the AI Airlock pilot programme that ran from April 2024 through to March 2025, including a summary of the pilot projects, early insights into recommendations and lessons learnt. You will also hear about the second phase of the programme including the key…
Ben Kemp
June 2, 2025
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2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations

Members have just over 2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations. This date sees a significant update to the UK Medical Device Regulation 2002 for IVDs and medical devices. Stuart Angell, Chair of BIVDA's Regulatory Affairs Working Party, provides a rundown of what members need to know: Systematic Data Collection: Manufacturers must establish and…
Ben Kemp
June 2, 2025
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Become a Certified PRRC – Join Our Expert-Led Virtual Training in June

Join our Upcoming PRRC Training Under the EU MDR and IVDR, the Person Responsible for Regulatory Compliance (PRRC) plays a critical role in ensuring that medical devices meet stringent regulatory standards throughout their lifecycle. Are you prepared to take on that responsibility, or to confirm that your team is ready for it? Join our two-part virtual PRRC training on June…
Ben Kemp
May 28, 2025
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