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Frequently asked questions on CE marking and conformity

The 11 most common questions on the CE procedure: when a machine needs CE marking, who may affix it, which steps are involved, what belongs in the EU declaration of conformity and how it differs from the declaration of incorporation.

All questions on CE marking and conformity

How does CE marking of a machine work?

CE marking is not a test seal but the manufacturer's declaration that the machine meets all applicable EU legislation. The path there: determine the applicable legislation, select standards, carry out the risk assessment, implement protective measures, compile the technical documentation, write the instructions for use, issue the declaration of conformity, affix the CE marking. Only then may the machine be placed on the market. Read in full

When does a machine need CE marking?

When it is placed on the EU market or put into service as machinery for the first time, including in-house builds for your own operation. Partly completed machinery receives no CE marking; it gets a declaration of incorporation. CE marking can also become necessary again after a substantial modification. Read in full

Who may affix a CE marking?

Only the manufacturer within the meaning of the Machinery Regulation or its authorised representative. The manufacturer is whoever places the machine on the market under their own name. That can also be the operating company that links up an installation itself, or the main contractor combining several trades into a complete installation. The role follows from what a party actually does, not from the title in the contract.

Which steps make up the CE conformity procedure?

Clarify the applicable legislation, determine the machinery category, select standards, carry out the risk assessment to EN ISO 12100, implement protective measures in design and technology, validate the safety functions, write the instructions for use, compile the technical documentation, sign the declaration of conformity, affix the CE marking. For high-risk machinery a notified body may be added depending on the case. Read in full

Which documents do I need for CE marking?

The technical documentation: general description, overall drawing with control circuit diagrams, detail drawings and calculations, risk assessment, list of applied standards and legislation, test and measurement records, instructions for use and the declaration of conformity. On top of that the declarations and data sheets for bought-in safety-related components. Read in full

How do I draw up an EU declaration of conformity?

It contains fixed mandatory content: manufacturer and, where applicable, authorised representative, unambiguous identification of the machine, applied legislation, applied standards with their edition, where applicable the notified body, place and date, plus the name and signature of the person authorised to sign. Varying the wording is possible; leaving out mandatory content is not. Read in full

What has to be in an EU declaration of conformity?

As a minimum: name and address of the manufacturer, identification of the person authorised to compile the technical documentation, description and identification of the machine including series or type designation, an express declaration of conformity with the relevant legislation, the harmonised standards applied, place and date of issue, and the identity and signature of the signatory. If one of these is missing, the declaration is formally incomplete. Read in full

What is the difference between a declaration of conformity and a declaration of incorporation?

The EU declaration of conformity belongs to machinery and declares conformity with all relevant legislation. The declaration of incorporation belongs to partly completed machinery; it names the essential requirements that have been met, states expressly that putting into service is prohibited until the final machinery has been declared conform, and undertakes to transmit the documents to the authority on request. Read in full

When do I need a declaration of incorporation?

Whenever you supply partly completed machinery, that is a product clearly intended to be incorporated into other machinery and which does not perform a function of its own. Assembly instructions are supplied together with the declaration of incorporation. CE marking under the Machinery Regulation must not be affixed in this case. Read in full

Who may sign a declaration of conformity?

A person authorised by the manufacturer to act with binding effect for the company, usually a managing director or an expressly authorised person. The signature is not a technical confirmation by the design engineer but a legally binding declaration by the company. It should therefore only be given once the technical documentation is genuinely complete. Read in full

How long do CE documents have to be kept?

At least ten years from placing the machine on the market. For series production the period starts with the last unit delivered. During that time the documents have to be complete, legible and unambiguously assignable to the machine in question. Read in full

Sources and standards

Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.

Heinrich Knutas
Heinrich Knutas
Machinery safety engineer
Founder of Kaidoc.app · CEO of Knutec.de · LinkedIn

Has been guiding CE projects in machinery, plant and special purpose engineering for years. That work led to Kaidoc.app, a software for standards-based CE documentation. Through Knutec.de the same work is available as a personal service.

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This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.

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