Bringing an AI-powered MD to the European market

A MedTech startup developing an AI-based lung nodule detection software engaged LIS Consulting to secure CE marking in Europe. Challenge: Determining the correct regulatory pathway under MDR, classifying the software as a Class IIb SaMD, generating sufficient clinical evidence, and addressing AI-specific requirements such as explainability and future algorithm updates. Our Approach: LIS Consulting developed the regulatory strategy, prepared the SaMD classification rationale, structured the clinical evaluation, and established a process for managing future AI modifications. Outcome: The software achieved CE marking under MDR 2017/745 (Class IIb) within 18 months, supported by a robust technical file, Clinical Evaluation Report, and Post-Market Clinical Follow-Up plan.