Compliance frameworks

CE Marking

Manage the EU conformity assessment process for high-risk AI systems, from classification through registration.

Overview

CE Marking is the EU's conformity certification for high-risk AI systems. Before you can market or deploy a high-risk AI system in the EU, you need to classify it, complete a conformity assessment, sign a declaration of conformity, and register it in the EU database.

The CE Marking tab in VerifyWise walks you through this process step by step, tracking progress and linking the policies, evidence, and incidents that support your compliance claim.

Accessing CE Marking

  1. Open a project from your dashboard.
  2. Click the CE Marking tab.
  3. The first time you open this tab, a default record is created with all 7 conformity steps set to "Not started."

Classification & scope

Start by answering 3 questions that determine your system's regulatory scope:

FieldWhat to select
High-risk AI systemYes or No. If Yes, the full conformity assessment workflow applies.
Role in productIs the AI system standalone, a safety component, part of a larger product, or a foundation model in a downstream system?
Annex III categoryWhich of the 8 high-risk categories applies (biometric ID, critical infrastructure, education, employment, essential services, law enforcement, border control, or justice/democracy).

Conformity assessment steps

The conformity assessment is a 7-step process. Each step can be assigned to a team member with a due date, and tracked through these statuses: Not started, In progress, Completed, or Not needed.

  1. Confirm high-risk classification — Verify that the system falls under Annex III and requires conformity assessment.
  2. Complete EU AI Act checklist — Work through the applicable controls and requirements.
  3. Compile technical documentation — Assemble the required technical documentation file.
  4. Internal review and sign-off — Internal stakeholders review and approve the documentation.
  5. Notified body review — If required, submit documentation to a notified body for independent review.
  6. Sign declaration of conformity — The authorized signatory signs the formal declaration.
  7. Register in EU database — Submit the system's details to the EU database.

A progress bar at the top shows how many steps are completed out of the total. Click any step row to update its status, owner, due date, or completion date.

Declaration of conformity

The declaration section tracks the formal document that states your AI system meets EU requirements:

FieldWhat it captures
StatusDraft, Ready for signature, Signed, or Archived
Signatory nameWho signed the declaration
Signed onDate the declaration was signed
Declaration documentLink or reference to the signed document

EU database registration

After signing the declaration, you register the system in the EU database. Track the registration status here:

FieldWhat it captures
StatusNot registered, Pending, Registered, or Rejected
EU registration IDThe ID assigned by the EU database
Registration dateWhen the system was registered
EU record URLDirect link to the EU database entry

Linking policies, evidence, and incidents

At the bottom of the CE Marking page, you can link supporting resources from other parts of VerifyWise:

  • Policies: Link governance policies that define how the system is managed and operated.
  • Evidence: Attach evidence files that demonstrate compliance with specific requirements.
  • Incidents: Connect any incidents that occurred during the system's operation.

These links create a traceable connection between your conformity claim and the documentation that supports it.

Who can do what

ActionRequired role
View CE MarkingAny authenticated user
Update classification and scopeAdmin or Editor
Update conformity stepsAdmin or Editor
Update declaration and registrationAdmin or Editor
Link policies, evidence, incidentsAdmin or Editor
PreviousFundamental Rights Impact Assessment
NextPost-market monitoring
CE Marking - Compliance frameworks - VerifyWise User Guide