High-risk conformity assessment and registration

What it does

It makes release of a high-risk system conditional on the legal steps being complete. Where the organisation is the provider, it carries out the conformity assessment, draws up the declaration, applies the marking and registers the system. Where it is the deployer, it obtains the provider's declaration and completes any registration of its own. Compliance or legal owns the process; the system owner supplies the evidence. It operates before first use and at each substantial modification.

How to implement it

• Identify high-risk systems and the organisation's role for each, from tiering.
• Determine the assessment route that applies to each system.
• Assemble the evidence: risk management, data governance, documentation, logging, oversight, accuracy and security.
• Draw up and retain the declaration and complete registration.
• Obtain declarations and instructions for use from suppliers before deployment.
• Define what counts as a substantial modification and reassess when one occurs.

Evidence it operates

Design: a conformity procedure with roles and a definition of substantial modification. Operation: for each high-risk system, the assessment record, declaration and registration reference; supplier declarations on file; a reassessment following a modification.

Where it fits

A gate at approval and deployment for the systems that AI risk tiering identifies. It is the primary control for conformity assessment and registration failure, relies on model and system documentation for its evidence, and takes its dates from the AI regulatory obligations register.

Limits

It applies only to systems recognised as high-risk, so it inherits every error in classification. Conformity is assessed against requirements whose supporting standards are still being written. The assessment shows that the requirements were met when it was done; continuing compliance depends on monitoring and change management. For Annex III systems the obligations apply from 2 December 2027.