The European Medical Device Regulation (EU MDR) imposes rigorous requirements for Clinical Evaluation Reports (CERs), demanding high levels of clinical evidence, traceability, and ongoing surveillance. This session explores how Artificial Intelligence (AI) can be used to streamline the development of CERs while maintaining compliance with EU MDR standards.
Participants will gain insight into the role of AI in literature screening, data extraction, and report drafting. The session will also address regulatory expectations and limitations around AI usage to ensure accuracy, transparency, and audit-readiness. Real-world examples and practical workflows will illustrate how to integrate AI effectively into your clinical evaluation processes.
Learning Objectives:
Understand how AI technologies can support key components of the clinical evaluation process under EU MDR.
Identify which tasks in CER development are best suited for AI assistance, including literature review, data synthesis, and risk-benefit analysis.
Evaluate compliance considerations and potential pitfalls when incorporating AI tools into regulated documentation.
Apply best practices for integrating AI outputs into human-led quality systems and regulatory submissions.
Explore real-case scenarios of AI-assisted CER generation and post-market clinical follow-up (PMCF) planning.
