Praxikon
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The conclusion and your first steps

Direct answer

What does the Article 9 risk management system require from us?

You describe: You are the provider of a high-risk AI system and must show that you structurally identify, mitigate and keep tracking risks to health, safety and fundamental rights. Likely role: provider (you place the system on the market).

This applies now

  • For this situation, the preparation phase matters most right now.

Coming up

Article 9 does not ask for a one-off risk analysis but for a continuous process across the entire lifecycle, with periodic review and attention to reasonably foreseeable misuse. The core obligations for Annex III systems apply from 2 December 2027; building the process takes longer than the remaining period suggests.

Your first actions

  1. Set up an iterative risk management process. Identify and analyse known and reasonably foreseeable risks, evaluate them and take measures, repeating the cycle on every change.
  2. 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.
  3. Set up data governance per dataset. Assess origin, representativeness, errors and completeness and examine possible bias with appropriate mitigation.
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

From obligation to arranged and demonstrable

Knowing where you stand is step one. Embed AI translates this obligation into a concrete approach for your organisation: scope, ownership, register and evidence.

See the Embed AI approach
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