Praxikon
All answers

Direct answer

What counts as high risk, and is our system one of them?

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 want to know whether your application falls into the regulation’s heaviest category, because nearly every further obligation depends on it. Likely role: deployer (you use the system).

The conclusion and your first steps

This applies now

Coming up

Then the Article 27 fundamental-rights assessment likely does not apply to you: it targets public organisations and credit and insurance use cases. Your duties as a deployer of a high-risk system remain fully in place, and if you process personal data a GDPR data protection impact assessment may be required independently. That is a different assessment, with a different purpose and a different supervisor.

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. Complete the conformity route before market placement. Select the correct assessment procedure, draw up the EU declaration of conformity, affix the CE marking and register in the EU database.
  3. 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