Molly Rogers
Molly Rogers is Head of IVDR for Medical Europe at DNV, where she leads IVDR activities and supports manufacturers through conformity assessment and certification processes. She brings extensive experience in notified body operations, spanning pre-application, IVDR technical documentation assessment, auditing, and final certification, along with several years in industry working on various IVD design and development projects. Molly is committed to strengthening IVDR implementation and helping manufacturers achieve compliance in an evolving regulatory landscape.
Topics
How to Shepard Your IVDs Through the Tail of Legacy Devices Transition?
As the IVDR transition period enters its final phase, manufacturers face critical decisions that will determine which devices remain on the market and how smoothly they transition to full IVDR compliance.
This presentation will provide a practical roadmap for navigating the tail end of the legacy device transition, from portfolio rationalisation and prioritisation to preparing for conformity assessment. It will explore how to evaluate existing technical documentation and legacy data against IVDR expectations, identify common gaps, and determine where additional evidence may be required.
The session will also discuss key regulatory milestones and practical implementation considerations, including timing of Declarations of Conformity, transition to IVDR labelling, and maintaining compliance throughout the process. Attendees will gain actionable insights to help reduce regulatory risk, optimise resources, and successfully transition their remaining legacy devices under IVDR.