Table 2.

Comparative table: the AI Act proposal (incident) and the MDR (serious incident)

	AI Act proposal	MDR
Product	High-risk AI systems	Medical devices
Regulated entities	Providers of high-risk AI systems: A natural or legal person, public authority, agency or other body that develops an AI system or that has an AI system developed with a view to placing it on the market or putting it into service under its own name or trademark, whether for payment or free of charge	Manufacturers of medical devices: means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark
Definition	‘Incident’: any incident that directly or indirectly led, might have led, or might lead to (a) the death of a person or serious damage to a person’s health, to property or the environment, (b) a serious and irreversible disruption of the management and operation of critical infrastructure ‘Malfunctioning’ (undefined)	‘Serious incident’: any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person; (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health, (c) a serious public health threat
Event/conditions	Potential or occurred Shall constitute a breach of obligations under Union law intended to protect fundamental rights	Potential or occurred Reporting obligations also if aware—yet unsure—of potentially reportable incident
Timing	Immediately after the provider has established a causal link between the AI system and the incident or malfunctioning or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the providers becomes aware of the serious incident or of the malfunctioning	Immediately to no later than 15 days after becoming aware of the incident; 2 days in the event of a serious public health threat; or ‘immediately’, in the event of death or unanticipated serious deterioration of a person’s state of health
Authorities	Relevant market authority	Relevant competent authority

AI Artificial Intelligenc, MDR Medical Device Regulation