Definition

Conformity assessment

The procedure demonstrating that a product meets the essential requirements — internal control, EU-type examination or full quality assurance — before CE marking.

The process under Article 32 and Annex VIII by which the manufacturer demonstrates conformity with Annex I: internal control (Module A), EU-type examination followed by conformity to type (Modules B and C), or full quality assurance (Module H); a European cybersecurity certificate can substitute in defined cases. Default products may use Module A; important Class I products only with fully applied standards; Class II and critical products require a notified body. Successful assessment leads to the EU declaration of conformity and the CE marking.

Reference: Art. 32; Annex VIII · Regulation (EU) 2024/2847 on EUR-Lex

Updated 2026-09-12 · Paraphrase for orientation, not legal advice.