The Machinery Directive 2006/42/EC
This is the law your machine has to satisfy today, and until 19 January 2027. After that, the Regulation replaces it — but almost everything you build and quote right now still lands here.
The Directive sets the essential health and safety requirements a machine must meet before it goes on the European market. It applies to you as the manufacturer regardless of where you are established: there is no U.S. exemption, and no threshold below which a machine escapes it.
What it asks of you
Four obligations, and they are not sequential — they interlock.
- Meet the essential health and safety requirements. They cover the whole machine: guarding, control systems, stability, ergonomics, noise, emissions, markings, instructions. You do not have to follow harmonised standards, but if you do, you get a presumption of conformity for the requirements those standards cover — and if you do not, you have to demonstrate equivalence yourself, which is harder and more expensive.
- Run and document a risk assessment. Not a checklist. The record of what hazards exist, what you did about each, and what risk remains.
- Assemble a technical file, before the machine is placed on the market.
- Declare and mark. The Declaration of Conformity is yours to sign; the CE mark goes on the machine.
If you ship something that is not a complete machine
This is where most U.S. manufacturers actually sit, and it is the part that is almost never explained to them.
Partly completed machinery — an assembly that is almost a machine but cannot perform a specific application on its own, and is intended to be incorporated into something else. A drive unit, a handling module, a subsystem sold to an integrator.
Fact — check it yourself
If that is what you ship, you do not CE mark it, and you do not issue a Declaration of Conformity.
Directive 2006/42/EC, art. 13 · Annex II, 1.B
You issue two different things:
- A Declaration of Incorporation, stating which essential requirements you applied and fulfilled, confirming the relevant technical documentation was compiled, and containing an undertaking to transmit relevant information to national authorities on reasoned request — an undertaking that expressly does not override your intellectual property rights. It must also state that the partly completed machinery must not be put into service until the final machine it goes into has been declared in conformity.
- Assembly instructions, so whoever integrates it can do so safely.
Issuing a full Declaration of Conformity for partly completed machinery is a common and consequential mistake: it asserts a conformity you did not assess, and it silently transfers to you obligations that belong to the integrator.
Assemblies of machinery are the mirror image.
Fact — check it yourself
Where several machines — or machines and partly completed machinery — are arranged and controlled so that they function as an integral whole to achieve the same end, the assembly is itself a machine under the Directive.
Somebody has to CE mark the whole line, not just the units in it.
Directive 2006/42/EC, art. 2(a), fourth indent
That somebody is whoever put the line together. If you supply into a European line, it is usually not you. If you supply the whole line, it is. The distinction is worth settling in the contract, before it gets settled by an inspector.
Fact — check it yourself
One requirement that catches everyone here: the Declaration of Incorporation, like the Declaration of Conformity, names a person authorised to compile the technical documentation who must be established in the European Union.
Directive 2006/42/EC, Annex II, 1.B, point 2
Modifying an existing machine
If a machine already on the market is modified beyond what its manufacturer foresaw — new hazards, or existing risks made worse — whoever made the change may have created a new machine, and may have become its manufacturer, with the full obligation set that follows.
Under the Directive this question is answered by national guidance, and the answers are not identical across Member States. The Regulation settles it with a definition in the law itself, including modifications made by digital means. If you retrofit, upgrade or re-purpose machines in Europe, that change is worth understanding before 2027 rather than after.
What we do
- Risk assessment and user manuals.
- PL/SIL analysis.
- Robotics and collaborative robots.
- Cybersecurity risk assessment.
- EC/EU type-examination support — preparing the file and running the Notified Body relationship.
- Substantial modification — assessing whether a change makes you a manufacturer, before you make it.