Register in the EU database

Register the high-risk system (and required provider/system information) in the EU database before placing it on the market or putting it into service.

Applies to

Provider, Deployer

Scope

High-risk (Annex III use case)

Applies from

2027-12-02 — Stand-alone high-risk (Annex III) obligations apply

Derives from

Article 49

Primary source

Art. 49 AIA

Evidence an auditor expects

• EU database registration confirmation — Proof of registration of the high-risk system in the EU database prior to placement/service.

FAQ

What evidence do I need for Article 49?
EU database registration confirmation. Each should be contemporaneous, versioned, and traceable to the system version.

When does “Register in the EU database” apply?
From 2027-12-02 — Stand-alone high-risk (Annex III) obligations apply. It applies to: Provider, Deployer.

What fails an audit here?
Missing or retroactively-created documentation.

Legal source

Art. 49 AIA

Explained in the newsletter

• The EU AI database: what your systems must declare before going to market

Not legal advice. This is a practitioner reference generated from a cited knowledge base built on the primary legal text and official Commission guidance. Verify against the cited primary sources before relying on it for a compliance decision. See editorial standards & methodology.