Tackling a Whirlwind of Uncertainties: UK Medical Devices Market Access

Filmed on October 19, 2023 - Market entry in the UK is rapidly evolving. The UKCA mark for medical devices is in effect, new UK legislation is in place, and a transition period has been defined (and re-defined). Despite the many uncertainties, manufacturers have been developing strategies for UK market access and have started implementation. In this session, SGS as an MHRA/UK Approved Body will discuss the best practices, common challenges and lessons learned for UK market approval for Medical Devices. Attendees will be provided insight to help assess the impact on new and existing devices in the market, apply the UK requirements to the quality management system and learn how to update technical documentation towards UK compliance. 0:00 Introduction 2:54 Recap 8:42 Pro-innovation Regulations of Technologies Review 14:51 Current Regulatory Situation - A Progressive Standstill 18:10 MRHA Workstream 18:56 Regulatory Updates 24:07 Updated Transitional Arrangements of UK 27:10 New Items: Timeline 28:45 Possible Legislative Timetable for MHRA 30:44 Small Scale Regulatory Updates 34:03 UK vs EU 38:12 Approved Bodies Designation 38:56 What to do 39:11 To dos for the UK Government 43:06 Regulatory Strategies for Manufacturers 45:00 UKCA Certification Strategies 46:55 Things to keep in mind 48:39 SGS Academy - Training 49:17 Q&A Speakers Balázs Bozsik - Technical Director - MDD/MDR, SGS Greg Jacobson - Sales Director - Medical Devices, SGS Learn more: https://bit.ly/3TeJhe8 Follow us on LinkedIn: https://bit.ly/44lmAY1