When modifying a machine makes you its manufacturer

Two articles in this regulation can turn a company that has never built a machine into its manufacturer, with the entire Article 10 list attached. Both are short, neither is widely read, and both describe things that happen in ordinary commercial life without anyone thinking of them as regulatory events.

Your name on someone else's machine

Private labelling is the usual route in. You buy a machine, your badge goes on it, you sell it as yours - and for the purposes of this regulation you are now the manufacturer of it, subject to Articles 10 and 11. The technical documentation, the declaration, the ten year duties, the instructions. All of it, for a machine someone else designed.

The second limb catches the same thing without the badge: modifying a product already on the market in a way that might affect compliance. "Might be affected" is a deliberately low bar. It does not ask whether compliance actually broke.

Substantial modification

This is the one that catches end users, not just resellers. A factory that retrofits a robot cell, adds an axis, replaces a safety controller or rebuilds a line to do something it was not built to do can land here - and a factory is not a company with a CE department. The duty does not care.

The part that limits it

Read the scope clause carefully, because it is the only thing standing between a modification and the whole regulation. Where the modification affects the safety of only one machine within an assembly, the obligations attach to that affected machine rather than to everything around it - and what decides that is the risk assessment. Which means the risk assessment is not paperwork produced afterwards to justify a decision; it is the instrument that sets how far the duty reaches.

What this does to documentation

If Article 18 applies to you, every document in this section becomes yours for that machine. A technical file you did not build and may not have. Instructions covering the machine as it now is, not as it shipped, in the languages of the market it sits in. A declaration you sign on your own responsibility. And the ten year clocks start from your modification, not from the original sale.

The practical consequence for anyone hosting documentation: a modified machine needs its own documentation at its own address, because the original manufacturer's manual no longer describes it and their declaration no longer covers it. Pointing a plate at the original maker's website is exactly the thing that stops being true the moment Article 18 attaches.

What this guide does not cover

Where ordinary maintenance ends and substantial modification begins is the question everybody actually has, and it is not answered in the regulation - it turns on the risk assessment for the specific change, and the Commission guidance on the subject is worth more than anything we could say. Repairs, like for like replacement and routine servicing are not what Article 18 is aimed at. If you are near the line, that is a question for someone qualified to answer it, and the text quoted above is what to take to them.