Software editors · AI startups · Integrators

You build the system, the AI Act holds you accountable for it.

Software editor, AI startup or integrator placing a system on the European market- you're a "provider" under the AI Act, carrying the heaviest burden of proof in the regulation.

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Your situation

The provider's burden of proof

If you develop an AI system and place it on the market under your own name- or substantially modify/rebrand an existing system- you become a "provider" under Art. 3 of the AI Act, regardless of your size. Obligations apply from your first European customer, not from a revenue threshold.

For a high-risk system (Annex III), the provider must produce complete technical documentation, have conformity assessed, affix the CE marking and register the system in the EU database before any commercialisation. Underestimating this documentation burden is the leading cause of go-to-market delays we see among AI startups.

Your obligations

What the AI Act expects from a provider

01Risk management systemEstablish a continuous process to identify, estimate and mitigate risks across the system's entire lifecycle.Art. 9

02Data governanceDocument the provenance, quality and bias-detection measures for training, validation and test datasets.Art. 10

03Annex IV technical documentationProduce the complete technical file- design, architecture, data, performance, risk management- structured to the regulation's exact headings.Art. 11

04Automatic loggingDesign the system so it automatically records relevant events during its operation.Art. 12

05Transparency noticeProvide deployers with instructions for use, capabilities, limitations and the expected performance levels of the system.Art. 13

06Design for human oversightBuild in technical measures that allow deployers to exercise effective human oversight.Art. 14

07Conformity assessmentHave the system's conformity assessed- self-assessment or notified body depending on the use case- before placing it on the market.Art. 43

08EU Declaration of ConformityDraft and sign the declaration attesting the system's conformity with all applicable requirements.Art. 47

With DILAIG

From audit to complete technical file

01Structured Annex IV documentationGenerated from your audit answers, under the regulation's exact required headings- not a generic template.

02Declaration of Conformity ready to signDrafted in legal language, automatically verified- blocking fields flagged, status computed article by article.

03Transparency notice for your customersThe document your deployers need to meet their own obligations- generated in 5 languages if needed.

04Verification with every versionNew model version, new use case? Re-audit for free and regenerate your documents up to date.

Frequently asked

What providers ask most

As soon as you place an AI system on the European market under your name or brand- including white-labelling for a third party, or substantially modifying an existing third-party system.

Yes, for the substantive documentation obligations (Art. 9-15). The AI Act provides specific support for SMEs (regulatory sandboxes, authority assistance) but no exemption on documentation content.

It depends on the use case. Most Annex III high-risk systems can undergo self-assessment of conformity by the provider- some cases (biometrics notably) require a notified body. The audit identifies your exact procedure.

CE marking attests that the system meets all AI Act requirements, in addition to- not instead of- other CE regulations already applicable to the product (medical devices, machinery, etc.).

Your technical file, structured and verified.

The audit that feeds it is free and unlimited, no credit card.

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