Risk Management in "Other Clinical Investigations" According to Art. 82 MDR - Lessons Learnt from the EDITh Project

With the implementation of the EU Medical Device Regulation (MDR), clinical trials of clinical decision support systems (CDSS) now often fall under Article 82 of the MDR. This mandates systematic risk management even for academic feasibility studies. This article presents a risk management strategy based on the EDiTh project, which evaluated a CDSS for epilepsy treatment recommendations in accordance with the 2023 S2k guideline First epileptic seizure and epilepsy in adulthood. A Preliminary Hazard Analysis and System Failure Mode and Effects Analysis identified key error types such as incorrect diagnoses or dosing recommendations. Due to the potential for catastrophic harm, a dual-visit study design was implemented, including a second, blinded expert consultation via videoconference to independently confirm diagnosis and treatment decisions. This design supports both risk mitigation and assessment of guideline adherence as the primary endpoint. The risk matrix and study setup illustrate how safety and regulatory requirements can be met in academic environments, while offering insights for future MDR-compliant investigations of digital health technologies.