The European Commission has issued draft guidance on reporting serious incidents involving high-risk AI systems. The aim of the guidance and accompanying reporting template is to help providers of high-risk AI systems prepare for mandatory incident reporting to national authorities ahead of the obligations becoming enforceable in August 2026.
An AI system is high-risk if it is intended to be used as a safety component of a product, or is itself the product, and in addition it is required to undergo a third-party conformity assessment before placing it on the market or putting it into service. Most medical devices incorporating AI are likely to meet this definition and would consequently be classified as high-risk. As such, the guidance has implications for manufacturers of medical devices incorporating AI systems.
Medical device manufacturers will recognise an overlap in the definitions of serious incidents provided in the AI Act and the Medical Device Regulation 2017/745 (MDR). In both cases, serious incidents leading to death or a serious detrimental impact on a person’s health must be reported to the relevant national authority according to strict timelines.
While the MDR and AI Act share a common goal when it comes to reporting serious incidents – namely ensuring safety and accountability – there are also clear differences in the scope of reporting. A direct causal relationship between the serious incident and the device is reportable under both the MDR and the AI Act. Additionally for AI systems, indirect causation necessitates reporting. An indirect cause would be when the AI system influences human decisions, for example if a scan is misinterpreted leading the doctor to give an incorrect diagnosis, or if a patient is incorrectly classified as low risk for a particular health condition which then subsequently remains unscrutinized.
Serious incident reporting requires robust procedures that can be efficiently and effectively deployed by adequately trained employees. These procedures must cover the requirements in both the MDR and the AI Act, whilst recognizing both the overlap and the distinctions to ensure timely and correct reporting. With the help of the guidance, manufacturers now have time to prepare their procedures and their employees for the reporting obligations under the AI Act. Our team of regulatory affairs experts is ready to support you in preparing your organisation for reporting serious incidents involving medical devices incorporating AI.
