CLUSTER / THE DECISION MAP
Conformity assessment, CE marking, notified bodies, harmonised standards.
Conformity routes, declarations, marking, standards and common specifications, and the bodies that assess them.
IN THIS CLUSTER
12 guides.
How does conformity assessment lead to CE marking?
Lead guide to conformity assessment, the EU declaration of conformity, CE marking, harmonised standards, common specifications and notified bodies for high-risk AI systems.
Read guide ↗CLUSTER ARTICLEWhich conformity assessment route applies under Article 43?
Article 43 routes explained: Annex III point 1, Annex III points 2 to 8, and Annex I product systems, and when the notified-body route is mandatory.
Read guide ↗CLUSTER ARTICLEHow does internal control under Annex VI work?
Annex VI internal control explained: quality management verification, technical documentation examination, and the provider's responsibility for the assessment.
Read guide ↗CLUSTER ARTICLEHow does third-party assessment under Annex VII work?
Annex VII notified-body assessment explained: quality management and technical documentation assessment, certificates, surveillance and the provider's continuing responsibility.
Read guide ↗CLUSTER ARTICLEHow must CE marking be affixed under Article 48?
Article 48 CE marking explained: when it is affixed, where it appears, digital CE marking, and the prohibition on misleading marking.
Read guide ↗CLUSTER ARTICLEWhat must an EU declaration of conformity contain?
Article 47 and Annex V explained: the contents, sole responsibility, translation, retention and update of the EU declaration of conformity.
Read guide ↗CLUSTER ARTICLEHow do harmonised standards create a presumption of conformity?
Article 40 explained: harmonised standards, presumption of conformity, citation in the Official Journal, and what to do while standards are still in development.
Read guide ↗CLUSTER ARTICLEWhen do common specifications apply under Article 41?
Article 41 common specifications explained: when the Commission adopts them, their role alongside harmonised standards, and how providers should use them.
Read guide ↗CLUSTER ARTICLEWhat are notified bodies and notifying authorities?
Chapter III Section 4 explained: designation of notified bodies, the role of notifying authorities, requirements for bodies, and how to check a body's scope.
Read guide ↗CLUSTER ARTICLEWhen does a change require a new conformity assessment?
Substantial modification explained: what counts, what does not, the role of pre-determined changes, and the reassessment workflow.
Read guide ↗CLUSTER ARTICLEHow does registration link to conformity assessment?
Registration under Article 49 linked to conformity: what is registered, when, by whom, and how the database entry relates to the declaration and CE marking.
Read guide ↗CLUSTER ARTICLEWhat quality management system does Article 17 require?
Article 17 quality management explained: scope, proportionality, documentation, and the link to conformity assessment for high-risk AI system providers.
Read guide ↗