What Article 10 puts on the manufacturer

Article 10 is the longest list of duties in the regulation and the one every other role is defined against. An importer verifies that these were done. A distributor checks that the verification happened. An authorised representative can hold the results but cannot perform them. So this is the list everything else points back at.

Before the machine goes on the market

Four things in one sentence, in order: the technical documentation of Annex IV Part A, the conformity assessment, the EU declaration of conformity, the CE marking. The order matters, because the declaration states that the assessment was done and the marking states that the declaration exists. None of them can honestly be produced out of sequence.

Ten years of holding the file

Read this next to Article 10(7)(c) and notice they are different duties wearing the same number. This one is availability to market surveillance authorities, on request, of the technical documentation and the declaration. 10(7)(c) is availability online, to users, of the instructions. One can be a locked cabinet; the other cannot. Satisfying either does nothing for the other, and the most common mistake on this page is treating a document archive as though it discharged both.

The sentence also carries something easy to skim past: where it is relevant, source code or programming logic in the technical documentation has to be made available to national authorities on a reasoned request, if they need it to check the essential health and safety requirements. For a machine with safety-related software, the file is not only drawings.

The machine has to say what it is

Model, series or type, the year the manufacturing process was completed, and a batch or serial number where one exists. This is what makes a digital instruction address answerable: Article 10(7) requires the instructions to clearly describe the product model they correspond to, and a reader can only match a document to a machine if the machine is marked well enough to be matched.

And who you are

A single point of contact, in a language users and market surveillance authorities can easily understand, on the machine where that is possible. A website alone is not a postal address, and a postal address alone is no longer enough: the text asks for both.

Then the documentation duties

The instructions, the Annex III information and the declaration of conformity travel with the machine, and since Regulation (EU) 2023/1230 they may be digital on four conditions. Those conditions and the three different ten year clocks are long enough to have their own pages: see the guides on digital instructions, on the ten year availability requirement, and on languages.

Being outside the EU changes nothing

A manufacturer established outside the Union carries this list exactly as one inside it. What changes is who else is also on the hook: the importer picks up their own verification and retention duties under Article 13, and an authorised representative can be appointed to hold the file inside the Union. Neither of those moves a duty off the manufacturer. They add duties to someone else.

What this guide does not cover

Article 10 also carries series production controls, the corrective action and recall duties, and cooperation with national authorities, and Article 11 carries a parallel list for partly completed machinery. Conformity assessment itself, Annex I and the essential health and safety requirements are outside anything this site is a sensible source for. Read the official text, or ask a notified body.