Praxikon
All answers

Direct answer

Does our system fall under the definition of an AI system (Article 3)?

This falls under Annex III: high-risk AI. That obligation applies from 2 December 2027. There is one exception you have to assess yourself.

This could go the other way

  • A listed Annex III system may fall outside high-risk under the strict conditions in Article 6(3), except where it profiles. The assessment and registration must be documented.

First step: Justify the Article 6(3) exception against each individual condition.

You describe: You are unsure whether software, a computational model or a rule-based system legally qualifies as an AI system and thus falls under the regulation. Likely role: provider (you place the system on the market or into service).

The conclusion and your first steps

This applies now

Coming up

Then you are the provider. The design and documentation duties sit with you: you build the requirements into the system, record how it works and what it rests on, and declare before deployment that it meets the regulation. Note that you can become a provider without building anything: substantially modifying a purchased system or placing it under your own name takes over that role.

Your first actions

  1. Justify the Article 6(3) exception against each individual condition. Name which of the four Article 6(3) conditions you invoke, with facts, and separately justify why the system poses no significant risk of harm to health, safety or fundamental rights and does not materially influence the outcome of decision making.
  2. Take role- and context-specific AI literacy measures. Determine for each role, system and context which combination of instruction, guidance, practice or training is appropriate.
Read the official sourceChecked on

General interpretation, not legal advice. Checked against Regulation (EU) 2024/1689 and the Digital Omnibus (EU) 2026/1744; the official source remains authoritative.

Full map for your situation

Execution

Record the classification in an AI register

A classification without a register and ownership is not demonstrable. Embed AI guides classification, register and reassessment in a fixed approach.

See the Embed AI approach
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Zahed Ashkara, lawyer and AI governance specialist

Expert behind this page

Zahed Ashkara

Lawyer and AI governance specialist