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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.…
Read More
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:…
Read More
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…
Read More
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 -…
Read More
The agenda for BIVDA’s 2025 Regulatory Affairs Seminar in Birmingham on February 11 - 12 2025 has now been released. Expert figures in diagnostics regulation including David Lawson, Director of Medical Technology, Department of Health and Social Care; Robyn Meurant, Principal Consultant, ACT-IVD; and Megha Deviprasad Iyer, Director of Global Strategic Regulatory Affairs, Thermo Fisher, will lead sessions designed to…
Read More
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…
Read More
You can find the guidance here.
Read More
The Regulatory Affairs Seminar will be held on the 11th and 12 February 2025. BIVDA’s Regulatory Affairs Seminar brings together the UK’s leading regulatory specialists to learn and collaborate. Next year’s event is being held at the Grand Hotel, Birmingham. Tickets are available at £895 per ticket, the event is currently NOT on Eventbrite so please signal your interest by…
Read More
The MHRA recently announced a consultation on their statutory fees, running until 24th October. BIVDA have significant concerns about the suggestion of charging per GMDN code. As drafted, this could see fees increasing dramatically - from low hundreds of pounds to tens of thousands annually. The current regulatory transition may also see duplicate charging, where the same device is currently…
Read More
The World Health Organization (WHO) has released a draft version of its updated guideline on practices for national regulatory authorities’ (NRAs) implementation of collaborative registration procedures (CRP) to facilitate the marketing authorization of new medical products within their jurisdictions for products that have either been WHO-prequalified or approved by a stringent regulatory authority. Read more here.
Read More
