Are we a provider or a deployer?
A provider is anyone who develops a system and places it on the market or puts it into service. Under Art. 25(1) a deployer also becomes a provider by placing a system under its own name, substantially modifying it, or changing its intended purpose. Fine-tuning a bought-in model for a different purpose falls under this.
What belongs in the technical documentation?
It follows Annex IV and must be drawn up before placing on the market. It demonstrates that the system meets the requirements and allows authorities and notified bodies to assess it. It grows with every version and is at once the basis of the conformity assessment and the later evidence towards market surveillance.
- Evidence
- Documentation with version state and release, kept for ten years
Do we need a notified body?
For most Annex III systems internal control under Annex VI is sufficient. For biometric systems a notified body may be required. Clarify this early and plan for their capacity; substantial modifications require the assessment to be run again.
When must we register the system?
Before placing on the market or putting into service, in the EU database maintained by the Commission, under Art. 49(1) and Annex VIII. The entries are publicly accessible: check the details beforehand for trade secrets and for consistency with the declaration of conformity.
What is a serious incident and how quickly must it be reported?
It must be reported to the market surveillance authority of the member state concerned, immediately after establishing the link to the system, at the latest 15 days after becoming aware. In severe cases the deadline shortens to two days. Decide in advance who reports, to which authority and on which form; two days is short.
- Evidence
- Reporting process with deadlines and responsibilities
Which threats arise before operation?
Seven of the 52: three from the supply chain, namely infrastructure, models and datasets, and four from development, namely training data poisoning, targeted label poisoning, a backdoor in the model, and time-triggered hidden instructions. These seven are hard to detect in operation and must therefore be addressed beforehand.
What does the regulation require technically from a high-risk system?
Art. 15 requires accuracy, robustness and cybersecurity at an appropriate level, maintained across the life cycle. Added to this are logging under Art. 12, instructions for use for deployers under Art. 13, enabling human oversight by design under Art. 14, and data governance under Art. 10.
What applies to systems that generate content?
Outputs must be marked machine-readably as artificially generated, under Art. 50(2). Check whether your output chain preserves the marking: watermarks and metadata are frequently lost once content is converted, cropped or passed on through third parties. Existing generative systems must be retrofitted by 2 December 2026.
From when do the provider obligations apply?
In stages. Conformity assessment, registration, post-market monitoring and incident reporting have applied since 2 August 2026. The requirements for high-risk systems under Annex III take effect from 2 December 2027, under Annex I from 2 August 2028. Two new prohibitions apply from 2 December 2026.
We train our own model. Does something different apply to us?
Yes. Anyone providing a general-purpose AI model carries a separate set of 14 obligations, regardless of whether a high-risk system results from it. These include the technical documentation of the model under Annex XI, a policy for complying with copyright law, and a public summary of the training content. If the cumulative training compute exceeds ten to the power of twenty-five floating-point operations, notification of systemic risk to the Commission applies on top.
Our model predates August 2025. Do we have a deadline?
Yes, 2 August 2027. By then existing general-purpose models must be brought in line with the obligations of Chapter V. The effort usually lies in documenting training data and compute retrospectively. Start with the summary of the training content, because it becomes public and therefore needs the longest coordination.
- Evidence
- Retrospective documentation per model, with a schedule
What does the application explicitly not do for development?
It does not produce technical documentation and does not fill in Annex IV. It performs no conformity assessment and replaces no notified body. It reports nothing to authorities and registers nothing in the EU database. It tests no model and measures no accuracy.