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

Abstract

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 Haz