Navigating the UKCA Transition: Key Deadlines for Medical Device Manufacturers

Medical Device Global Market Access · Aug 15, 2025 · 2m

This episode breaks down the essential requirements of the UK MDR 2002, outlining the critical transition deadlines for moving from CE marking to the new UKCA mark. We cover the specific dates manufacturers need to know for 2028 and 2030, the mandatory role of the UK Responsible Person (UKRP), and the conformity assessment process with UK Approved Bodies. Learn the key steps to ensure your medical devices remain compliant for access to the Great Britain market. Key Questions: • What is the UKCA mark and how does it differ from the CE mark? • Can I still sell my CE-marked medical device in…