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Direct answer

How do we set up an AI register and classify our systems?

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 oversight: which AI systems run, who owns them, and which risk category applies per system. Likely role: deployer (you use the system).

The conclusion and your first steps

This applies now

Coming up

Then you are the deployer. Your vendor builds the system in conformity, you use it in conformity: according to the instructions for use, with human oversight that can genuinely intervene, and with the documents you should receive from them. Request the technical documentation and the declaration of conformity now; without them you cannot demonstrate your own duties later, and that is a contract question to raise before signing.

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.
  3. 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.
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