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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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The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The Therapeutic Goods Administration (TGA) has released its compliance principles for the next 2 years, setting out a refreshed approach to compliance and enforcement to protect public health. The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for…
Ben Kemp
January 23, 2026
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2025: Global Wireless Regulatory Overview

Global Wireless Regulatory Updates and Trends 2025   Considering regulatory changes early can help simplify your wireless product’s design, testing and certification processes — keeping your launch timeline on track.   Watch our on-demand webinar to receive the latest compliance updates impacting market access for Bluetooth, Wi-Fi, Cellular and short-range devices in Africa, Europe, Latin America, North America, the Middle East and Asia.   What you’ll learn: Key…
Ben Kemp
January 23, 2026
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Join Us: Shaping the Future of Clinical Trials in the Philippines – Exclusive Webinar

Dear Partners, We are delighted to invite you to our upcoming webinar, “Shaping the Future of Clinical Trials in the Philippines,” hosted by the IQVIA Philippines team. Date: Wednesday, February 4, 2026 Time: 9:30 pm – 10:30 pm SGT | 9:30 am – 10:30 am EST Join us for an insightful session featuring distinguished speakers from the Department of Health, Philippines FDA, and leading…
Ben Kemp
January 23, 2026
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