CE marking for machinery: straight answers for U.S. manufacturers

Nobody — there is no such thing as a CE certificate.

CE marking is not something you buy from a body. For machinery, you affix the CE marking, and you sign the EU Declaration of Conformity. The Declaration names “the person empowered to draw up the declaration on behalf of the manufacturer” — that person works for you, not for a certification body.

What does exist is an EC type-examination certificate, issued by a Notified Body. It applies to a narrow list of machinery categories, it is not called a CE certificate, and most machines never need one. If a European customer, a freight forwarder or a distributor asks you for “the CE certificate,” what they almost always need is your EU Declaration of Conformity — a signed document you produce yourself.

• What this means for your machine — Declaration of Conformity

Usually not. Under the Machinery Directive currently in force, a Notified Body is required only if your machine falls in a specific list — Annex IV — and you have not built it fully to the relevant harmonised standards.

Three cases, in order of how often we see them:

1. Your machine is not in Annex IV. Self-assessment. No Notified Body, at all. This is most industrial machinery.
2. Your machine is in Annex IV and is built fully to harmonised standards that cover all the relevant health and safety requirements. You may still self-assess. The Annex IV list alone does not force a Notified Body.
3. Your machine is in Annex IV and is not built fully to those standards. Now a Notified Body is required: either EC type-examination or a full quality assurance system.

Annex IV is short and specific — woodworking saws, presses for cold metalworking, injection moulding machines, underground machinery, vehicle servicing lifts, and a handful of others. If your machine is not on it, the answer is case 1.

This changes on 20 January 2027. Under the new Machinery Regulation, six categories move to a list where a Notified Body is mandatory even if you build fully to harmonised standards. See Q4.

• Find out which case you are in — Notified Body or self-certification?

Yes — for most machinery, self-assessment is the route the law expects you to take, not a loophole. It has a formal name in the Directive: assessment of conformity with internal checks on the manufacture of machinery.

Self-certifying does not mean “declare and ship.” It means you carry the whole burden yourself:

• a risk assessment, and a design that answers it;
• a technical file that demonstrates conformity, assembled before you place the machine on the market;
• instructions in the official language of each country where the machine is sold;
• an EU Declaration of Conformity you sign;
• the CE marking affixed to the machine.

The exposure is real: if a market surveillance authority asks for your technical file and you cannot produce it, the fact that you self-assessed is not a defence. Self-certification shifts the work to you — which is why most U.S. builders bring in an engineer who has done it before, rather than a certification body they do not need.

• What a compliant file actually contains — Technical file

The Machinery Directive is repealed and replaced, with no grandfathering for new machines. From that date, machinery placed on the EU market must comply with the Regulation. Machines placed on the market before 20 January 2027 in conformity with the Directive can keep being made available — the trigger is the date you place the machine on the market, not the date you built it.

A date worth getting right.

The four changes that actually move work onto your desk:

1. Six machinery categories can no longer be self-assessed at all. Removable mechanical transmission devices and their guards, guards for those devices, vehicle servicing lifts, portable cartridge-operated fixing and impact machinery, and safety components — or embedded systems — whose safety functions use self-evolving machine-learning behaviour. For these, a Notified Body is mandatory regardless of which standards you built to.
2. Machine learning in a safety function is now regulated explicitly. If a safety function adapts its own behaviour, that is a named category with a mandatory third-party route.
3. Cybersecurity becomes a health and safety requirement, not a customer expectation. Corruption of software or data must not create a hazardous situation.
4. Substantial modification is defined in the law. The question “have we modified this machine enough to become its manufacturer?” now has a legal answer instead of a national interpretation.

If your machine ships to Europe in 2027, the design decisions that determine the answer are being made now.

• The full 2027 readiness picture — Machinery Regulation 2023/1230

No. It is good engineering and it counts for nothing as evidence of EU conformity.

UL 508A and NFPA 79 are the North American framework. The EU asks a different question, answered by a different standard — EN 60204-1, the harmonised standard for the electrical equipment of machines — and the two are not interchangeable. The gaps that most often force rework on a panel that is already listed:

• Short-circuit rating. A UL 508A panel carries an SCCR. The EU asks you to demonstrate that the equipment withstands the prospective short-circuit current at the point of installation. Different question, different evidence.
• Disconnecting means and supply. Requirements for the supply disconnecting device, and for what may remain live behind it, do not map one-to-one.
• Protective bonding. Continuity and conductor sizing follow different rules.
• Conductor identification. Colour conventions differ, and this one is visible in five seconds to any European inspector.
• Documentation. EN 60204-1 expects a specific set of electrical documentation inside the technical file.

The honest version: a well-built UL 508A panel is a strong starting point, and the delta is a defined engineering task — not a redesign. But nothing about the listing transfers automatically, and the CE Declaration still has to be signed by you on evidence that speaks the EU’s language.

• We work in both directions — Talk to an engineer

The file must exist before the machine is placed on the market, and be available for at least ten years.

What it contains, in substance: a general description of the machine; the drawings, circuit diagrams and calculations needed to check conformity; the full risk assessment, with the hazards identified and the protective measures adopted; the standards applied; any test reports; the instructions; and a copy of the Declaration of Conformity.

Two things U.S. manufacturers are usually relieved to hear:

• It does not have to be in Europe. The Directive is explicit that the technical file need not be located in EU territory, nor kept permanently in material form.
• It does not have to be pre-assembled as one bound document — but it must be capable of being assembled and produced when an authority asks. In practice, “we could put it together in a few weeks” is not an answer that survives a reasoned request.

Two things that catch people out:

• The ten years are counted from a moving anchor. Under the current Directive, from the date of manufacture — of the last unit, for series production. Under the 2027 Regulation, from the date the machine is placed on the market. Same duration, different start.
• Someone in the EU has to be able to produce it. See Q8.

• A file that survives a real audit — Technical file

You. Always.

The Declaration identifies and is signed by the person empowered to draw it up on behalf of the manufacturer. A consultant cannot sign it for you, and you should be wary of one who offers to. What a consultant can do is make the document defensible: the right directives listed, the right harmonised standards referenced by their Official Journal citation, the Notified Body and certificate number where one exists, and every claim traceable to something in the technical file.

We do the engineering and the file. The signature is yours.

• What the Declaration must contain — Declaration of Conformity

If you have no company, importer or fulfilment provider established in the EU, then yes — and it is a condition for placing the machine on the market at all.

Under the EU market surveillance regulation, a machine may be placed on the EU market only if there is an economic operator established in the Union responsible for a defined set of tasks: holding the Declaration of Conformity at the disposal of authorities, ensuring the technical documentation can be produced on request, answering reasoned requests in a language the authority understands, and cooperating on corrective action. That operator can be a manufacturer established in the EU, an importer, an authorised representative with a written mandate, or a fulfilment service provider.

Two details that decide the answer for most U.S. builders:

• This applies to machinery, ATEX equipment and pressure equipment alike — all three are named in the regulation’s list.
• The name and contact details of that operator must appear on the product, its packaging, the parcel or an accompanying document. It is not a filing you keep in a drawer; it is printed information a customs officer or inspector can read.

If you sell through a single European distributor who imports under their own name, that importer may already be the operator — and you should know that, because they then carry obligations you depend on. If you sell direct, or through several channels, you should appoint an authorised representative.

Two things decide it, and your machine’s complexity is not one of them.

First: how much already exists. If you have a risk assessment, drawings, test reports and a manual, the work is review and gap-closing — we are checking evidence you already produced. If the risk assessment has never been done, that is the project. It is the single largest piece, it cannot be shortcut, and it is the difference between two projects that look identical from the outside.

Second: whether a Notified Body is involved. A Notified Body adds a queue you do not control to a schedule you do. This is why Q2 is worth answering before you promise a delivery date to anyone — and why, from 20 January 2027, some manufacturers will discover they need one when they never did before.

What we can tell you quickly, and for free. Send us the machine and the destination market and we will come back with the route: which directives apply, whether a Notified Body is in the loop, and which of your existing documents count as evidence. That answer is specific to your machine, it costs nothing, and it is the only honest basis for a number.

What we will not do is quote you from a table. Two machines in the same category, with the same function, routinely sit at opposite ends of any range — because one of them has a design file and the other has a folder of PDFs. A published price range would be right for one of them and misleading for the other.

The one thing that reliably makes a project cost more: starting the compliance work after the machine is built. Everything found at that point is a change to hardware, not a change to a document.

• Get the route for your machine — Talk to an engineer

Today, and until 19 January 2027: the Machinery Directive 2006/42/EC. From 20 January 2027: the Machinery Regulation (EU) 2023/1230. There is no overlap period in which you may choose.

What decides which one applies is the date the machine is placed on the EU market — not when you designed it, not when you built it, not when the purchase order was signed. A machine built in 2026 and placed on the market in February 2027 is a Regulation machine.

Two consequences worth planning around:

• A long-lead project straddles the change. If you are quoting today for delivery in 2027, design to the Regulation now. Retrofitting the new requirements onto a finished design costs more than building them in.
• Existing EC type-examination certificates stay valid until they expire. If a Notified Body issued you one under the Directive, it does not become void on 20 January 2027.

• A readiness review of your current design — Talk to an engineer