Navigating the UKCA Transition: Key Deadlines for Medical Device Manufacturers

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 Great Britain? • What is the absolute final deadline for transitioning to the UKCA mark? • Do the transition timelines differ for devices under the EU MDR versus the older MDD? • What are the responsibilities of a UK Responsible Person (UKRP)? • Is it mandatory for a non-UK based manufacturer to appoint a UKRP? • How do the regulations for Northern Ireland differ from the rest of the UK? • What are the first steps my company should take to prepare for the UKCA transition? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.