What counts as partly completed machinery (Article 3(10))
An assembly which is not yet machinery as it cannot in itself perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming machinery.
Your obligations as the manufacturer (Article 11)
| Duty | Where in the Regulation |
|---|---|
| Design and build to the relevant essential health and safety requirements | Art. 11(1), Annex III |
| Draw up the technical documentation before placing on the market | Art. 11(2), Annex IV Part B |
| Keep the file and the declaration of incorporation for at least 10 years; source code or programming logic on reasoned request where needed | Art. 11(3) |
| Procedures so series production stays in conformity | Art. 11(4) |
| Mark designation, year of construction, model, series or type and any batch or serial number (or on packaging/accompanying document) | Art. 11(5) |
| Contact address: a single point of contact, in a language the integrator and authorities understand | Art. 11(6) |
| Supply assembly instructions; digital allowed, paper free of charge within one month if requested at purchase; online for at least 10 years | Art. 11, Annex XI |
| Supply the EU declaration of incorporation, or give its web address or machine-readable code in the assembly instructions | Art. 11, Annex V Part B |
| Corrective action, withdrawal or recall; inform authorities where there is a risk | Art. 11(9) |
What the declaration of incorporation must include (Annex V, Part B)
- Name and address of the manufacturer and, where applicable, its authorised representative.
- For lifting machinery that can only be assembled at the place of use, the address of that place.
- References to harmonised standards or common specifications applied, with their dates; if only partly applied, which parts.
- An undertaking to transmit relevant information to national authorities on reasoned request, including the method of transmission.
- A statement that the partly completed machinery shall not be put into service until the final machinery has been declared in conformity with the Regulation.
Annex V Part B lists further items (identification of the product and the declaration statement); use the full list from EUR-Lex or our template.
Points to check
- Issuing a CE-marked declaration of conformity for an assembly that is really partly completed machinery, or the reverse.
- Not saying which Annex III requirements were applied and fulfilled, leaving the integrator to guess.
- Assembly instructions that describe installation but not the conditions the integrator must meet to keep the final machine safe.
- Digital instructions or declarations with no stable link kept online for 10 years.
FAQ
Does partly completed machinery get a CE mark?
No CE marking is listed among the Article 11 duties. The supplier issues an EU declaration of incorporation (Annex V, Part B), and the final machine is CE marked by whoever completes it and declares it in conformity.
Can the declaration of incorporation be digital?
Yes. Article 11 allows the internet address or machine-readable code to be given in the assembly instructions, and digital declarations must stay accessible online for at least 10 years.
How long must the file be kept?
At least 10 years after the partly completed machinery is placed on the market, together with the declaration of incorporation.
General information, not legal advice or certification. Source: Regulation (EU) 2023/1230 Article 3(10), Article 11, Annexes III, IV Part B, V Part B and XI, on EUR-Lex.
Related: declaration of conformity contents · technical documentation (Annex IV) · digital instructions · transitional rule. We sell to businesses only; see Terms.