BIVDA Updates Regulatory Affairs Newsletter Archive

BIVDA updates Regulatory Affairs Newsletter BIVDA Updates Regulatory Affairs Newsletter Archive Membership News Membership News Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

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 KempFebruary 3, 2026

Less than three weeks to go until BIVDA’s Regulatory Affairs Seminar

There are less than 3 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham and just a few tickets are now remaining. We are pleased to announce that Kim Young, Regional Engagement Director, RAPs will present a session on The Future of Regulatory Affairs. This year's theme is 'Think Locally, Act Globally', dedicating a day…

Ben KempJanuary 19, 2026

Only 6 weeks to go until BIVDA’s Regulatory Affairs Seminar

There are only 6 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham — and it promises to be the must-attend event for diagnostics regulatory professionals across the UK, Europe, and beyond. This year's theme is 'Think Locally, Act Globally', dedicating a day each to UK and international regulation to help attendees maximise opportunities and…

Ben KempDecember 9, 2025

BIVDA/NN Translations Webinar: How to Work Effectively with Language Service Providers and Translators

Taking place on 16 December, 1:00 PM – 2:00 PM GMT, NN Translations Founder Nataliya Nedkova will host a webinar about one of the most challenging, often misunderstood areas of medical device and IVD regulatory compliance: translation workflows. What will the webinar explore? 🔹 The hidden challenges behind medical and regulatory translations 🔹 How to work effectively with LSPs and…

Ben KempDecember 9, 2025

Registration opened for BIVDA’s 2026 Regulatory Affairs Seminar

After last year’s record-breaking event, BIVDA is excited to hold the 2026 Regulatory Affairs Seminar, between 10–11 February in Birmingham. This year promises to be bigger than ever — unmissable for any regulatory affairs professional in diagnostics. Whether you’re driving innovation to market, steering post-market strategy, or hungry for expert insight into where UK regulations are heading, this seminar is…

Ben KempSeptember 9, 2025

New Chair of UKCA Subgroup announced

BIVDA is pleased to inform members that James Barker (Cytocell) has accepted the post of co-chair of the UKCA Subgroup. James will work alongside the existing chair, Emma Barringer. James is a regulatory professional with almost 20 years of experience in the IVD sector, currently serving as Regulatory Affairs Manager at Oxford Gene Technology (OGT) in Cambridge, UK. Over the…

Ben KempJune 17, 2025

Working Party Chair and Vice Chair changes

BIVDA would like to update members on a number of changes to working party chairs and vice chairs. Regulatory Affairs Working Party Alison Gilles, Leica BioSystems, steps up at the Regulatory Affairs Working Party as Vice Chair, meaning that we’re back to full complement. UKCA Subgroup Emma Barringer is moving from chairing the Environmental WP to chairing the UKCA Subgroup.…

Ben KempMay 19, 2025

Get discounted MedBoard services with your BIVDA membership

Thanks to our partnership with MedBoard, members can receive discounts on the first year of their MedBoard subscription. MedBoard is an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. empowering professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. By using the code BIVDAMEDBOARD, the following discounts will apply:…

Ben KempApril 29, 2025

BIVDA announce partnership with MedBoard

BIVDA is excited to announce a new partnership with MedBoard, an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. MedBoard empowers professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. As part of this collaboration, BIVDA members can enjoy exclusive discounts on their first-year MedBoard subscription – a…

Ben KempFebruary 12, 2025

AI/ML Software as an IVD Chair and Vice-Chair Nominations

Following the call for nominations for the role of chair and vice chair for the AI/ML Software as an IVD subgroup, we have received two nominations. Please find below statements from the two candidates. If we receive no objections by Close of Business Friday 14th Feb 2025, the nominees will be appointed. Tsz Wai Woo – IVDeology - Nominee -…

Ben KempFebruary 4, 2025