Post-Brexit MedTech: Your Guide from FDA to UKCA Marking

Medical Device Global Market Access · Aug 9, 2025 · 3m

This episode breaks down the essential steps for medical device manufacturers with FDA clearance to successfully enter the post-Brexit UK market. We clarify why FDA approval isn't recognized by the MHRA and detail the two main pathways to achieving UKCA certification: leveraging the CE mark transition period and direct conformity assessment. Learn about critical deadlines, the role of the UK Responsible Person, and how to stay compliant. Key Questions: • Does my FDA 510(k) clearance fast-track UK market access? • What is the UKCA mark and how does it differ from a CE mark? • Can I still use…