OBL-ART13-04Binding
Undergo the applicable conformity assessment procedure
- Applies to
- Manufacturer
- Source citations
- Art. 13(4)Art. 32Annex VIAnnex IIIAnnex IV
- Product classes
- DefaultImportant — Class IImportant — Class IICritical
Last reviewed
Plain language
Before you affix the CE mark, you must prove conformity using the right process for your product type. Most default products can self-assess. Important or critical products — those listed in Annexes III and IV — need an independent third-party auditor (a notified body) to check your work, at least partially.
Legal text
Article 13(4) of Regulation (EU) 2024/2847 requires that manufacturers shall comply with the conformity assessment procedures referred to in Article 32, prior to placing a product on the market.
Article 32 sets out the routes:
- Default products — Module A (internal production control, Annex VI Module A). The manufacturer assesses conformity themselves without third-party involvement.
- Important Class I products (Annex III) — Module A is available if harmonised European cybersecurity standards or common specifications are applied. Otherwise, Module B+C (EU-type examination) or Module H (full quality assurance) are required.
- Important Class II products (Annex III) and Critical products (Annex IV) — always require a notified body: Module B+C or Module H.
Conformity assessment routes
| Product class | Route | Notified body? |
|---|---|---|
| Default | Module A | No |
| Important Class I (with harmonised standards) | Module A | No |
| Important Class I (without standards) | Module B+C or H | Yes |
| Important Class II | Module B+C or H | Yes |
| Critical | Module B+C or H | Yes |
Key requirements
- Identify product class before selecting a conformity route (see Annexes III and IV)
- Apply harmonised standards where available to maximise self-certification options
- Engage a notified body if required — check the NANDO database for accredited bodies
- Complete the assessment before CE marking — CE must not be affixed until conformity is established
Evidence you may need
- Product classification rationale (Annex III / IV analysis)
- Completed Annex VI Module A checklist (for self-certification)
- Notified body certificate (Module B) where applicable
- Quality-management system certificate (Module H) where applicable