Which procedure applies (Article 25)
| Machinery | Procedures the manufacturer may apply |
|---|---|
| Not listed in Annex I (most machines) | Internal production control (module A, Annex VI). |
| Annex I Part B | Module A (Annex VI), but only if designed and built to harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. Otherwise: EU type-examination (module B, Annex VII) plus conformity to type (module C, Annex VIII); or full quality assurance (module H, Annex IX); or unit verification (module G, Annex X). |
| Annex I Part A | Module B plus C; or module H; or module G. Internal production control alone is not available. |
What is in Annex I Part A
- Removable mechanical transmission devices including their guards, and guards for them.
- Vehicle servicing lifts.
- Portable cartridge-operated fixing and other impact machinery.
- Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.
- Machinery with embedded systems of that kind that have not been placed independently on the market, in respect of those systems only.
Part B lists further categories; check the current Annex I text for yours. The Part A entries on machine-learning safety functions are new compared with Directive 2006/42/EC.
Checklist before 20 January 2027
- Check every product line against Annex I Parts A and B.
- For Part B, record whether you rely on harmonised standards or common specifications; if not, plan a module B+C, H or G route.
- For Part A, plan notified-body involvement early: lead times are yours to confirm with the body.
- Record the chosen procedure in the technical documentation and the declaration of conformity.
General information, not legal advice or certification. Source: Regulation (EU) 2023/1230, Article 25 and Annex I, on EUR-Lex.
44-point gap checklist
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Excel, each row cites its Article or Annex. See which files you must update.
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