EU AI Act Database Registration: When and How to Register Your AI System

One of the EU AI Act's less-discussed requirements is also one of the most concrete: before you place a high-risk AI system on the EU market, you must register it in the EU database for high-risk AI systems. This is not optional, not deferrable, and failure to register means your system cannot legally operate in the EU.

Who must register

Article 49 creates registration obligations for two groups:

• Providers of high-risk AI systems must register the system itself in the EU database before placing it on the market or putting it into service. This includes the system's technical details, intended purpose, and conformity assessment status.
• Deployers of high-risk AI systems that are public authorities (or act on behalf of public authorities) must register their use of the system. Private-sector deployers are not currently required to register, but they have other obligations under Article 26.

If you are a provider operating from outside the EU — a US company selling AI software to EU customers, for example — you must register through your EU authorised representative. You cannot register directly without an EU presence.

What information is required

The database registration requires detailed information about your AI system. Based on Annex VIII of the EU AI Act, you need to provide:

• Provider details. Company name, address, contact information, and EU authorised representative details if applicable.
• System identification. Name, version, and a unique identifier for the AI system.
• Intended purpose. A clear description of what the system does and the context in which it operates. This must match the intended purpose documented in your Annex IV technical file.
• Risk classification. Which Annex III category the system falls under and the basis for the classification.
• Conformity assessment. The type of conformity assessment performed (internal or third-party), the date of the EU declaration of conformity, and any notified body involvement.
• Member States. Which EU member states the system is or will be available in.
• Status. Whether the system is on the market, in service, recalled, or withdrawn.
• URL for instructions for use. A link to the system's instructions for deployers, as required by Article 13.

Most of this information should already exist in your Annex IV technical documentation. Registration is essentially publishing a structured subset of that documentation to a public database.

When to register

The timing requirements are strict:

• Before market placement. Registration must be completed before the AI system is placed on the EU market or put into service for the first time. You cannot retroactively register after launch.
• After conformity assessment. Since registration requires conformity assessment details, it logically comes after you have completed the conformity assessment process and issued the EU declaration of conformity.
• Updates required. If any registered information changes — new version, new member states, change in status — you must update the registration without undue delay.

For systems already on the EU market before the enforcement deadline, there is a transition period to complete registration. However, new systems placed on the market after the high-risk deadline (561 days away) must be registered before launch.

Step-by-step registration process

While the EU AI Office is still finalising the exact technical implementation of the database, the practical steps are clear:

• Step 1: Complete your Annex IV technical documentation. The database pulls from this — you cannot register without it. Use the document generation tools to accelerate this.
• Step 2: Complete your conformity assessment. Determine whether your system requires internal assessment or a third-party notified body. Most Annex III systems can self-assess unless they involve biometrics.
• Step 3: Issue the EU declaration of conformity. This is a formal declaration that your system meets all applicable requirements. Template format is specified in Annex V.
• Step 4: Register in the database. Create an account in the EU AI database (managed by the EU AI Office), enter the required Annex VIII information, and submit.
• Step 5: Apply CE marking. After registration and conformity assessment, apply the CE marking to your system. The CE marking signals compliance to the market.

After registration: ongoing obligations

Registration is not a one-time event. After registration, you must:

• Keep information current. Any change to registered details must be updated promptly. This includes new software versions, expanded geographic availability, and changes to intended purpose.
• Report serious incidents. If your AI system causes or contributes to a serious incident — a death, serious health damage, serious property damage, or serious environmental damage — you must report it to the relevant market surveillance authority and update the database.
• Update on withdrawal or recall. If you withdraw or recall the system from the EU market, the database entry must be updated accordingly.
• Respond to authority requests. Market surveillance authorities can request additional information about your registered system at any time. You must respond within specified timeframes.

The EU database is designed to be a public transparency tool. Parts of your registration will be publicly visible, allowing anyone — regulators, deployers, affected persons — to look up your AI system and verify its compliance status. Treat this as a public commitment.

The practical recommendation: do not wait until you are ready to register to start thinking about it. Work backwards from the database fields. Make sure your technical documentation, conformity assessment, and declaration of conformity are all complete well before you need to press submit. The high-risk deadline is 561 days away. Classify your AI system now to understand which registration obligations apply.