Certain apps with clinical purposes will need to be compliant with the AIA from 2 August 2025. This is the case, for example, where they qualify as medical devices that fall into Annex III (and Article 6(2)) of the AIA.

Annex III includes AI systems intended for public authorities to evaluate the eligibility of a person for public benefits, such as hospital triage systems or system for determining mental health support. These only fall under the high-risk definition in the context of Annex III where they pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by materially influencing the outcome of decision making.

The deadline for medtech products that fall under Annex I and are high-risk AI systems, meanwhile, and which encompasses AI-enabled medtech products that fall under the scope of the Medical Device and IVD Regulations, is 2 August 2027. 

These devices will require additional notified body certification under the AIA.

2 August 2025 is also the date by which the AIA’s provisions on notified bodies and the governance structure for notified bodies assessing AI should apply.

This is so that the infrastructure related to the governance and the conformity assessment system can be operational before 2 August 2026.

This does not give much time for the designation of notified bodies under the AIA themselves and then to have certified their clients’ innovative medical devices which fall under the AIA’s Article 6(1), and which are due to be placed on the market on or shortly after 2 August 2027.

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