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The EU Declaration of Conformity

This is the document your European customer is actually asking for when they say “the CE certificate.”

It is one page. You write it, you sign it, and with your signature you take personal responsibility — on behalf of your company — for the statement that the machine complies. There is no counter-signature, no laboratory stamp, and no consultant who can carry it for you.

That makes it the shortest document in the file and the one worth getting exactly right.

What it must contain

Ten items under the Machinery Directive in force today:

  1. Business name and full address of the manufacturer — and of the authorised representative, where there is one.
  2. Name and address of the person authorised to compile the technical file, who must be established in the European Union. — see below; this is the one that stops people.
  3. Description and identification of the machine: generic denomination, function, model, type, serial number, commercial name.
  4. An express statement that the machine fulfils all the relevant provisions of the Directive — plus similar statements for any other directives it complies with. The references must be those of the texts as published in the Official Journal, not an informal shorthand.
  5. The Notified Body that carried out the EC type-examination, with its identification number and the certificate number, where applicable.
  6. The Notified Body that approved the full quality assurance system, where applicable.
  7. The harmonised standards used, where applicable.
  8. Other technical standards and specifications used, where applicable.
  9. Place and date.
  10. The identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or the authorised representative.

Two more rules that catch people out: the Declaration and its translations follow the same language conditions as the instructions, and it must be typewritten or handwritten in capital letters.

Item 2, and why it stops U.S. manufacturers

Fact — check it yourself

The person authorised to compile the technical file must be established in the European Union.

Read it against your own situation. If your company has no legal presence in Europe — no subsidiary, no branch, no appointed representative — there is nobody whose name and address can go on that line. And a Declaration with an empty line 2 is not a valid Declaration.

Directive 2006/42/EC, Annex II, 1.A.2

This surprises people because it is not the same requirement as the market-surveillance obligation you may already have heard about. They are two separate rules, from two separate laws, and you can satisfy one while failing the other:

  • Person authorised to compile the technical file

    Where it comes from Machinery Directive, Annex II What it asks A named person, established in the EU, on the Declaration itself

  • Responsible economic operator

    Where it comes from EU market surveillance regulation, Article 4 What it asks An EU operator whose contact details appear on the product or packaging

A single appointed representative can cover both. But it has to be appointed, in writing, before you place the machine on the market — not after a customs officer asks.

What the Declaration does not cover, and why that protects you

Fact — check it yourself

The Declaration relates exclusively to the machine in the state in which it was placed on the market.

It expressly excludes components added, and operations carried out, subsequently by the final user.

Directive 2006/42/EC, Annex II, 1.A (preamble)

This is not fine print — it is a boundary drawn in the Directive itself, and it works in your favour. If a customer bolts on a third-party feeder, bypasses an interlock, or integrates your machine into a line you never saw, that is outside what you declared. Whoever makes those changes may be creating a new machine, and may become its manufacturer.

Which is exactly why the Declaration has to identify your machine precisely — model, type, serial number. A vague identification makes the boundary vague, and a vague boundary is not a boundary.

What changes on 20 January 2027

The Regulation replaces the EC Declaration with the EU Declaration of Conformity, and the content list changes in five ways worth planning for:

  1. 1.You must state explicitly that the declaration is issued under your sole responsibility. It becomes a required line, not an implication.
  2. 2.Harmonised standards need their Official Journal publication date, and if you applied a standard only partly, the Declaration must say which parts. Citing “EN ISO 12100” is no longer enough.
  3. 3.The EU-established technical file compiler disappears from the Declaration. That line — item 2 above, the one that blocks U.S. manufacturers today — is not among the particulars the Regulation requires. This is not a relaxation. The EU-side obligation moves rather than vanishes: an authorised representative’s mandate must let them keep the technical documentation and the Declaration at the disposal of national authorities for at least ten years, and produce them on reasoned request. Notably, the Regulation also states that drawing up the technical documentation cannot be part of that mandate — the manufacturer keeps that work.

The practical translation: from 2027 you no longer need someone in Europe to compile the file, but you still need someone in Europe who holds it and answers for it.

  1. 4.Substantially modified machinery is named on the Declaration. The Regulation’s Declaration identifies “machinery or related product, or substantially modified machinery” — the modification question now has a place on the form.
  2. 5.Smaller things that make life easier: you may include a colour image where it helps identify the machine, and numbering the Declaration is explicitly optional.

The four ways a Declaration goes wrong

  • Directives listed by habit. Copy-pasted from the last machine, including one that does not apply and missing one that does. Every wrong entry is a false statement you signed.
  • Standards cited that were never applied. A list of impressive references with nothing in the technical file behind them. This is the fastest way to turn a documentation query into an investigation.
  • Line 2 filled with the consultant’s name. We are asked to do this regularly, and we decline. The person authorised to compile the technical file carries a real obligation; putting a name there because it is an EU address does not create the relationship the Directive assumes.
  • Signed by someone who cannot be found. The person named in the Declaration is the person who must be able to produce the file. If they have left, the machine’s paperwork has a hole in it that grows for ten years.

What we do

We draft the Declaration against the technical file, not against a template: every directive listed because it applies, every standard listed because it was used and is evidenced, every reference in the form the Official Journal publishes it.

What this is not

You sign it.