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Evaluation ViewAttendees 42

Devices (includes Medical Devices and In Vitro Diagnostics)

Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access

Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT
Location/Room: 510A
Advanced Level
Description: UK market entry is rapidly evolving.  The UKCA mark in in effect, new UK legislation is in place, and a transition period has been defined.  Despite the many uncertainties, manufacturers have been developing strategies for UK market access and have started implementation. In this session experts from industry, MHRA/UK Approved Body and UK Responsible Person will discuss best practices, common challenges and lessons learned for the UK market approval.  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. Combining the perspectives of all stakeholders will give insight into the delta between foreign regulations and UK requirements, and how foreign approvals may be leveraged toward UK market access.

Learning Objectives:

  • Describe the do's and don'ts of UK compliant technical documentation
  • Understand the current regulatory expectations for the UK and the impact of changing regulations on a device portfolio
  • Understand the impact on the quality management system