PMCF Requirements Are Raising Hard Questions About Cost, Device Viability, And Where AI Fits In

EU MDR post-market clinical follow-up (PMCF) requirements are reshaping how medical device teams plan and budget for post-market evidence. For many organizations, the cost of generating this evidence now rivals the commercial return of keeping a device on the market—turning evidence strategy into a critical business decision rather than a regulatory checkbox.

In this 60-minute discussion, Castor CEO Derk Arts and EU MDR expert Dr. Bassil Akra tackle the questions device teams often struggle to get straight answers on: what AI-assisted chart review can realistically contribute to evidence generation, when real-world data collected in the US may support European submissions, and how to estimate PMCF costs before committing to a study design. Viewers walk away with a five-step framework for incorporating AI into PMCF strategy. For teams facing rising evidence-generation costs and uncertain regulatory pathways, this conversation offers a clearer way to evaluate options and build a more efficient, defensible approach to meeting EU MDR post-market obligations.