How manufacturers demonstrate conformity (harmonized standards, technical documentation, conformity assessment modules, EU declaration and CE marking) and how national market surveillance authorities check products and enforce the regulation.
How harmonized standards cited in the Official Journal, Commission common specifications and European cybersecurity certification schemes give a presumption of conformity with Annex I, and where the CRA standards program stands.
Drawing up the EU declaration of conformity (Annex V) or the simplified declaration (Annex VI), combining declarations across EU laws, and affixing the CE marking, including for software and with a notified body number under module H.
What the Annex VII technical file must contain (product description, architecture, vulnerability handling processes including the SBOM, risk assessment, support period basis, standards applied, test reports, declaration), when it is drawn up and how long it is kept.
Choosing the conformity assessment route (module A internal control, EU-type examination with module C, full quality assurance under module H, or an EU cybersecurity certification scheme) according to whether the product is default, class I, class II or critical.
Who enforces the regulation and how: national market surveillance authorities under Regulation (EU) 2019/1020, access to data and documentation, evaluations of products presenting significant risk, corrective measures, sweeps and coordination through ADCO.
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