normakte / Conformity assessment
Whether you may assess conformity yourself or need a notified body depends on whether the machine is listed in Annex I — and whether harmonised standards cover all requirements.
| Machine | Possible procedures | Notified body |
|---|---|---|
| Not in Annex I | Internal production control (module A) | no |
| Annex I Part B, harmonised standards or common specifications cover everything | Module A, or B+C, H, G | not for A, otherwise yes |
| Annex I Part B, standards do not cover everything | EU type-examination + internal production control (B+C), full quality assurance (H) or unit verification (G) | yes |
| Annex I Part A | B+C, H or G | always |
If a notified body is involved, its identification number appears next to the CE marking. The rules on notified bodies have applied since 20 January 2024 — if you need one, ask early.
Chosen procedure, certificates and declaration together — with article references.
Sources. Regulation (EU) 2023/1230, OJ L 165 of 29.6.2023; Regulation (EU) 2024/2847, OJ L, 2024/2847 of 20.11.2024. Summarised; only the official text is authoritative. normakte is not legal advice.