Providers who have concluded under Article 6(3) that their Annex III system is not high-risk must still register. They submit provider identification, system trade name and identification, intended purpose, the conditions under Article 6(3) justifying the non-high-risk determination, a short summary of the grounds for this conclusion, and the system’s status.

This registration is particularly important because it creates a public record of the provider’s self-assessment. If a market surveillance authority later disagrees with the classification, the registered justification becomes central evidence. The Article 6(3) justification must therefore be thorough and defensible, consistent with the CDR analysis.

A superficial registration that states the conclusion without supporting reasoning invites scrutiny. The Legal and Regulatory Advisor reviews the registration justification before submission, confirming it accurately reflects and is supported by the CDR.

Key outputs

• Article 6(3) justification registered as public record
• Consistency with CDR analysis verified
• Legal review before submission
• Module 10 AISDP evidence