Glossary

CE marking

The visible result of complete technical documentation: risk assessment to EN ISO 12100, design records, test reports, operating instructions and the EU declaration of conformity. From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies in place of Machinery Directive 2006/42/EC.

Also
Machinery Directive · Machinery Regulation (EU) 2023/1230 · Declaration of conformity
Also known as
  • Machinery Directive
  • Machinery Regulation (EU) 2023/1230
  • Declaration of conformity
01

What the CE mark says – and what it does not

By affixing the CE mark the manufacturer declares that the product complies with all applicable EU legislation. It is a declaration on the manufacturer’s own responsibility, not a test seal and not a quality mark. For most machinery no independent body checks; the manufacturer assesses conformity and is liable for it being correct.

For machinery the legal basis is the Machinery Directive 2006/42/EC. From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies in its place, directly in all member states.

02

The route in six steps

The conformity assessment procedure follows a fixed order. It starts with the design, not after it.

  • Identify the applicable legislation – besides machinery law, depending on the product, EMC, pressure equipment or ATEX for example.
  • Carry out a risk assessment to EN ISO 12100 and define protective measures.
  • Apply harmonised standards; they give a presumption that the requirements they cover are met.
  • Compile the technical file.
  • Write operating instructions in the language of the country of use.
  • Issue the EU declaration of conformity and affix the CE mark.
03

The technical file

The technical file includes the description of the machine, drawings and circuit diagrams, the risk assessment, calculations and test results, the standards applied and the operating instructions. It is not supplied with the machine but must be kept for ten years and presented to market surveillance authorities on request.

Without the file, conformity cannot be demonstrated – the mark on the nameplate alone proves nothing.

04

Special cases: partly completed machinery, lines, in-house builds

Partly completed machinery – a drive system, for example, or an assembly that can perform a specific application only once incorporated into a machine – does not receive CE marking under machinery law but a declaration of incorporation and assembly instructions. Whoever links several machines into a line becomes the manufacturer of the assembly and assesses its interfaces.

Machinery built for one’s own use is also covered. And whoever substantially modifies an existing machine takes on the manufacturer’s duties for the modified machine.

05

What the Machinery Regulation changes

Regulation (EU) 2023/1230 keeps the basic principle. New elements include requirements on protection against corruption and on systems with self-evolving behaviour, an explicit rule on substantial modification and the option of providing instructions digitally. For manufacturers this mainly means moving the declaration of conformity and the documentation to the new legal basis in good time.

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Overview

Which document goes with which product

Product Declaration Accompanying document CE mark
Complete machine EU declaration of conformity operating instructions yes
Lifting accessory EU declaration of conformity operating instructions yes
Partly completed machinery declaration of incorporation assembly instructions no, not under machinery law
Linked production line EU declaration of conformity for the assembly operating instructions for the line yes
Frequently asked questions

Frequently asked questions about CE marking

Is the CE mark a test seal?

No. It is the manufacturer’s declaration that the product meets the EU requirements. A notified body is involved only for certain categories of machinery and procedures listed in machinery law.

Does a fixture built for one’s own plant need a CE mark?

If it is a machine or a lifting accessory within the meaning of EU machinery law, yes. The law does not distinguish between products that are sold and products that are used by their maker.

Who signs the declaration of conformity?

The manufacturer or its authorised representative established in the EU. The declaration also names the person authorised to compile the technical file.

Does CE marking remain valid after a conversion?

Only if the conversion is not a substantial modification. If a new hazard arises, or a risk increases so that additional protective measures become necessary, the machine has to be reassessed.

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