SOTA: Breaking the Chicken-Egg Loop

Description:
Evaluating the state of the art is a cornerstone of clinical evaluation under the MDR, but it remains one of the most debated elements. Despite MDCG guidance and international standards, definitions and applications vary widely across manufacturers, notified bodies, and regulators.

This joint session will bring together perspectives from a manufacturer, a notified body, and an ISO working group member. It will explore how state of the art evaluation should be understood not as a standalone deliverable, but as a process interlinked with clinical evaluation and risk management during design & development and post-market surveillance.

Particular attention will be given to the evolving ISO 18969 requirements, and how they shape expectations for integrating state of the art into clinical evaluation practice. Participants will gain insight into the different lenses through which state of the art is assessed and how to navigate potential gaps between regulatory intent, notified body review, and practical implementation in industry.

By the end of the session, attendees will have a clearer roadmap for aligning their clinical evaluation strategy with both MDR and international standards while building stronger internal and external alignment.