Post-Market Surveillance for Software as a Medical Device

This technical report discusses the complexities of post-market surveillance (PMS) for Software as a Medical Device (SaMD). It outlines the challenges faced by regulatory bodies like the FDA and EMA in differentiating between true software defects and non-defect issues stemming from user errors, configuration mismatches, and environmental factors. The report emphasizes the importance of structured and risk-informed approaches to accurately classify complaints, which can significantly reduce unnecessary investigations and operational burdens. It highlights that a substantial percentage of reported issues are not actual defects but rather arise from user interaction challenges and other external factors. The document details regulatory requirements, including FDA’s 21 CFR Part 822 and EU MDR 2017/745, and discusses the role of standards such as IEC 62304 in integrating PMS with software risk management. By improving classification practices, organizations can enhance investigation efficiency and ensure compliance with safety and performance standards.