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CLSI – Guidance documents update

New and updated standards Shop | Clinical & Laboratory Standards Institute Includes M100 Antimicrobial Susceptibility Testing 2026 EP05 Plus – Evaluation of Precision of Quantitative Measurement Procedures 4th Ed Dec 2025 MM19 – Establishing Molecular Testing in Medical Laboratory Environments Nov 2025   Documents for Public Review | CLSI EP17-Ed3 (Proposed Draft) - Evaluation of Detection Capability for Medical Laboratory…
Ben Kemp
February 6, 2026
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RADIANT CERSI Innovators Survey

The RADIANT CERSI has launched an innovators survey aimed at better understanding the regulatory challenges and support needs of digital health and AI innovators. The CERSI network is supported by MHRA and UKRI. RADIANT aims to bridge the gap between regulatory science and real-world innovation, creating a sustainable and inclusive ecosystem for SMEs and innovators in Digital Health and AI. RADIANT…
Ben Kemp
February 3, 2026
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NIHR: Introduction to the EU Diagnostic Medical Devices Regulation (EU) 2017/746 – Online interactive workshop

🕰️ Tuesday, 24 February 2026, 10am to 12pm Are you developing a in vitro diagnostic device for the health sector? Are you unsure if you need to adhere to the In Vitro Diagnostic Medical Device Regulations? Or what the risk classification of your device is according to the In Vitro Diagnostic Medical Device Regulations? Or which requirements your device need…
Ben Kemp
February 3, 2026
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BIVDA cited in Parliament as MHRA annual fees are announced

Health Minister Baroness Merron last week announced in Parliament that MHRA fees will be set at £300 per year, based on Level 2 GMDN terms. This will take effect from 1 April 2026 to fund the MHRA’s post-market surveillance (PMS) activities. Overall, this move has been welcomed by BIVDA members. We were glad that the MHRA reconsidered the initial fees…
Ben Kemp
February 3, 2026
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FDA Consensus recognized standards update 20260219

Dear members please see a stripped down version of the FDA Consensus recognised standards update 19th Feb 2026. I’ve removed irrelevant subject matter entries and highlighted those in Green that maybe relevant to IVDs. Original source : Federal Register :: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065
Ben Kemp
February 2, 2026
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QServe and TUV SUD – Navigate AI in MedTech: Live Regulatory Insights

We'd like to invite you to a live, practical webinar on Ensuring Quality in AI Driven Devices, hosted by Qserve experts and a guest speaker from Notified Body TÜV SÜD. We will unpack the regulatory expectations, explain what TÜV SÜD assesses during a submission review, and share examples from real-world cases, including those involving AI-supported clinical evaluation activities. Thursday, January 29,…
Ben Kemp
January 23, 2026
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MedTech Europe update on EUDAMED progress

Mandatory use of the first four EUDAMED modules (Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance) starts as of 28 May 2026 EUDAMED PLG v3.22 released on 12 December: This release includes updates reflecting feedback from the VGL CA Board’s coordinated testing. According to the release notes, it is now possible to change the referenced device in…
Ben Kemp
January 23, 2026
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