Topic
Conformity assessment
Modules, routes, and choosing the cheapest honest path.
The route question — who checks conformity — is decided by classification: internal control (Module A) for default products, conditions for Annex III classes, Modules B+C, Module H or a certification scheme at 'substantial' level for class II, and a European certification scheme where available, otherwise the class II procedures, for critical products F-026. Whatever the route, the outputs are the same: a technical file, the declaration of conformity F-021, and the CE marking F-027, which the manufacturer affixes under Article 13(12).
The current friction
The class I self-assessment condition can be met by applying harmonised standards, common specifications or a European cybersecurity certification scheme in full F-026, and no CRA harmonised standards have been cited in the Official Journal as of the facts date F-036 — the practical route picture for class I stays unsettled until that changes.
Verified facts this page relies on
- F-026 Conformity routes: default products may use internal control (Module A), EU-type examination plus internal production control (Modules B+C), full quality assurance (Module H) or a European cybersecurity certification scheme; important class I must use B+C or H (or a scheme at 'substantial' level) unless harmonised standards, common specifications or such a scheme are applied in full; important class II must use B+C, H or a scheme at 'substantial' level; critical products use a European scheme where available, otherwise the class II procedures. Art. 32(1)–(4), Annex VIII
- F-036 No harmonised standards for the CRA have been cited in the Official Journal as of the facts date; the Commission’s standardisation request M/606 covers 41 standards, with the first deliverables expected in Q3 2026. Commission / CEN-CENELEC
- F-021 EU declaration of conformity (Annex V) and simplified declaration (Annex VI). Art. 28, Art. 13(12), (20), Annex V, Annex VI
- F-027 CE marking is affixed visibly, legibly and indelibly to the product, or where not possible to the packaging or the declaration of conformity/accompanying documents; for software, on the declaration of conformity or the website accompanying the product. Art. 29–30
Facts are maintained and human-verified in the CEMarque Facts Table (v2026.09.4, verified 2026-09-10).
Editorial review: Claude (AI reviewer, delegated by the editor), 2026-10-08. Methodology and correction process: how this site works.
Related in the reference
- Article 32 — Conformity assessment procedures for products with digital elements
- Annex VIII — Conformity assessment procedures
- Topic: Harmonised standards