Praxikon
All answers

Direct answer

Do we have to report serious incidents with our AI system?

This falls under Article 73: serious incident reporting. That obligation applies from 2 December 2027. There is one exception you have to assess yourself.

This could go the other way

  • For systems under sectoral reporting regimes with equivalent duties, reporting may run through that regime to avoid duplication.

First step: Set up an incident process with reporting routes.

You describe: Something goes wrong with a high-risk AI system and you need to know whether that is a reportable incident, who to report it to and within what deadline. Likely role: provider (you place the system on the market).

The conclusion and your first steps

This applies now

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

Coming up

The deadline depends on severity: at most 15 days after establishing the causal link, 10 days in case of death and 2 days for a widespread infringement or serious disruption of critical infrastructure. As a deployer you do not report to the authority yourself but inform the provider without delay.

Your first actions

  1. Set up an incident process with reporting routes. Define what a serious incident is, assign the reporting route to the supervisor and rehearse the process.
  2. Draw up a post-market monitoring plan. Systematically collect and analyse real-world data on the system’s performance and compliance throughout its lifetime.
  3. Design logging into the system. Ensure the system automatically records events relevant to risk identification and post-market monitoring.
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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Zahed Ashkara, lawyer and AI governance specialist

Expert behind this page

Zahed Ashkara

Lawyer and AI governance specialist