Is my system high-risk? A plain checklist

Question 1: Is it a safety component of a regulated product?

If the AI is part of a product covered by EU product-safety law in Annex I (for example a medical device, machinery or a toy) and that product needs a third-party conformity assessment, the AI is high-risk. These rules apply from 2 August 2028.

Question 2: Is it used for something listed in Annex III?

The Annex III areas are:

• Biometrics (remote identification, categorisation by sensitive traits, emotion recognition).
• Critical infrastructure (safety components in traffic, water, gas, heating, electricity, digital infrastructure).
• Education (admissions, grading, steering learning, detecting cheating).
• Employment (recruiting, screening, promotion, firing, task allocation, monitoring performance).
• Essential services (public benefits, credit scoring, life and health insurance pricing, emergency call triage).
• Law enforcement, migration and border control, and the administration of justice and elections.

If no, it isn't high-risk under Annex III. If yes, carry on.

Question 3: Does it profile people?

If the system profiles people (automatically evaluates aspects of their life, such as work performance, finances, health or behaviour), it is high-risk. The exceptions below don't apply.

Question 4: Does one of the narrow exceptions apply?

An Annex III system is not high-risk if it doesn't materially influence decisions about people, because it only:

• performs a narrow procedural task (for example turning unstructured data into structured data);
• improves the result of a human activity already completed (for example polishing a letter a person wrote);
• detects patterns or deviations from earlier decisions without replacing or influencing the human assessment;
• performs a preparatory task for an assessment (for example translating documents).

When this applies

Obligations for Annex III high-risk systems apply from 2 December 2027. Use the time to build the controls; most of them take months, not weeks.