Everplate
EU Machinery Regulation
Article 11, Article 22, Annex V Part B

Partly completed machinery: a different document, and a different declaration

If you make something that is meant to be built into another machine, you do not issue a declaration of conformity. You issue a declaration of incorporation under Article 22, and you ship assembly instructions rather than instructions for use.

Component and sub-assembly makers read guides about the Machinery Regulation and find almost all of them describing finished machines, CE marking and declarations of conformity - none of which they issue. Article 11 is their list, and it runs parallel to Article 10 rather than inside it.

“When placing partly completed machinery on the market, manufacturers shall ensure that it has been designed and constructed in accordance with the relevant essential health and safety requirements set out in Annex III.”
Article 11(1)

Note the word "relevant". A partly completed machine cannot meet every essential requirement, because some of them only make sense once it is built into something. It must meet the ones that apply to it, and the technical documentation has to show which, and why the rest do not.

Annex IV Part B, not Part A

“Before placing partly completed machinery on the market, manufacturers shall draw up the technical documentation set out in Annex IV, Part B.”
Article 11(2)
“Manufacturers shall keep the technical documentation and the EU declaration of incorporation at the disposal of the market surveillance authorities for at least 10 years after the partly completed machinery has been placed on the market. Where relevant, the source code or the programming logic included in the technical documentation shall, upon a reasoned request, be made available to the competent national authorities, if that source code or programming logic is necessary in order for them to be able to check compliance with the relevant essential health and safety requirements set out in Annex III.”
Article 11(3)

The same ten year clock as a finished machine, counted from placing on the market, and the same source code provision. What differs is which part of Annex IV you are building against and which declaration it supports.

Assembly instructions, not instructions for use

“Manufacturers shall ensure that the partly completed machinery is accompanied by the assembly instructions set out in Annex XI.”
Article 11(7)

A different document with a different audience. Instructions for use address the operator of a finished machine; assembly instructions address the manufacturer who is going to incorporate your component, and they live in Annex XI. They may be digital on the same four conditions as instructions for use - marked on the product, printable and savable, online for the duration.

The declaration of incorporation

“The EU declaration of incorporation shall state that the fulfilment of the relevant essential health and safety requirements set out in Annex III has been demonstrated.”
Article 22(1)
“The EU declaration of incorporation shall have the model structure set out in Annex V, Part B. It shall be continually updated and shall be translated into the language or languages required by the Member State in which the partly completed machinery is placed on the market or is made available on the market.”
Article 22(2)

Annex V Part B rather than Part A, "continually updated" rather than signed once, and translated for the market the partly completed machinery is placed on. The same language duty as everything else in this regulation.

“Digital EU declarations of incorporation shall be made accessible online for at least 10 years after the placing on the market of the partly completed machinery.”
Article 11(8)

And its own availability rule, which is the one place partly completed machinery is treated more lightly: at least ten years after placing on the market, with no "expected lifetime" clause attached. For a component built into a machine with a thirty year service life, that is a shorter duty than the machine around it carries.

No CE marking

Partly completed machinery does not carry CE marking under this regulation, because it is not yet a machine that can be declared conforming. Affixing one anyway is a common and expensive error - it asserts something untrue about a product that by definition is not finished, and it misleads the manufacturer who incorporates it into thinking the assessment is already done.

What this guide does not cover

Whether a given product is partly completed machinery at all is the question underneath this page, and it is a definitional one that turns on Article 3 and on what the thing can do on its own. Get that wrong and every document above is the wrong document. Annex XI sets out what assembly instructions must contain. Nothing here is legal advice.

Everplate is where this documentation lives

Upload the manuals and declarations you already have and you get a QR code, plate artwork and a permanent address, in every language you sell into. Published revisions are never deleted, so what you served in 2027 is still provable in 2037.