Table 3.

Summary of the MDF requirements (illustrated by the MDR) relevant to AI' insider transparency measures.

Who to whom:	AI providers to themselves;
When:	During the whole life cycle of AI-device;
What:	– Information provision (as specified at the internal transparency level); – Development of explanations for AI systems; – Documentation of the whole process of the device's development, its risk management system, conformity assessment and post-market surveillance; – Keeping the records of: • Carrying out of conformity assessment procedures; • Incidents and adverse effects of a device; • Quality management and reports; • Clinical investigations; • Data about devices' safety and quality.
How:	Records-keeping and documentation shall be carried out in the way that enables notified bodies to audit the activities of AI provider and verify the quality and safety of AI devices. Explanations shall be provided to the maximum technically possible extent and in way that enables further tailor explanations to users. Information shall be provided as specified at the internal transparency level.
Why:	• To hold AI providers accountable; • To ensure safety and quality of AI-devices.