With new legislative updates and shifting timelines across the UK and EU regulatory landscape, understanding what’s changing - and what it means for your business - is more important than ever.
Join us for this essential webinar during BSI’s Healthcare Week 2025, where our regulatory experts will walk through the latest updates to EU MDR, EU IVDR, and UK MDR 2002, helping you decode the evolving compliance requirements and understand what steps to take next.
This session is a must for manufacturers, consultants, and regulatory professionals operating in or targeting the UK and EU medical device markets.
What we'll cover:
- EU MDR: Updated transition timelines and the implications of EU Regulation 2023/607.
- EU IVDR: Key changes under EU Regulation 2024/1860 and what they mean for diagnostics manufacturers.
- UK MDR 2002: The current status of legislative reform, proposed timelines, and post-market surveillance (PMS) requirements.
You’ll leave with a clear understanding of how these updates impact your regulatory pathway and what proactive steps you can take now to ensure continued market access and compliance.
Why Attend?
This webinar offers a timely opportunity to gain clarity on the latest EU and UK regulatory changes affecting medical devices.
Whether you're a manufacturer, consultant, or regulatory professional, understanding how updated transition timelines and legislative reforms impact your certification pathways is critical to staying compliant and competitive.
With expert-led insights and practical guidance, this session will help you navigate the evolving regulatory landscape with confidence
Webinar Details:
Date: 11 June 2025
Time: 12:00 - 13:00 BST
Location: Online
Agenda
12:00 – 12:05 Welcome & Introduction
Vishal Thakker, BSI
12:05 – 12:15 MDR Update
Maddalena Pinsi, BSI
12:15 – 12:25 IVDR Update
Sara Fabi, BSI
12:25 – 12:35 UKCA Update
12:35 – 12:55 Q&A
12:55 – 13:00 Close
