Table 2.

Summary of the Medical Devices Framework (illustrated by the MDR) requirements relevant to AI' internal transparency measures.

Who to whom:	AI provider to healthcare professional (device's user) and patient;
When:	When a device is placed on the market and being used;
What:	Providing of information about: • Instructions for the appropriate use of a device; • Safety and quality of a device; • Expected clinical benefits; • device's performance characteristics; • Information allowing assessment of the device's suitability; • Residual risks, contra-indications, and any undesirable side-effects; • Information allowing being informed about risks, contra-indication, and undesirable side-effects; • Requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons; • Specifications the user requires to use the device appropriately.
How:	Information relevant to the user and tailored to his technical knowledge, experience, education, or training. Instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
Why:	• To enable healthcare providers making choices, including diagnosis and treatment ones; • To hold healthcare providers accountable, including with regards their transparency obligations toward patients; • To ensure safety and quality of AI-devices, both at the general level and with regards to the specific patient.