CE marking: an overview of the steps

CE marking applies to products placed on the market of the European Union — including those imported into it, which is why manufacturers outside the EU face the same obligations when they sell into this market. For machines, the path leads through seven steps that build on one another: each provides the basis for the next, which is why skipping a stage leaves the marking vulnerable to challenge at the end.

1. Determine the applicable legal acts – which directives and regulations apply at all?
2. Carry out the risk assessment – the core from which everything else follows.
3. Select harmonised standards – they specify the requirements in concrete terms.
4. Create the technical file – the evidence that the requirements are met.
5. Conformity assessment – internal or with the involvement of a notified body.
6. Issue the EU declaration of conformity – the signature with which the manufacturer assumes responsibility for conformity.
7. Affix the CE marking – only now, not before.

At the start is the question of which legal acts apply at all. For machines, this is today the Machinery Directive 2006/42/EC, and from 20 January 2027 the Machinery Regulation (EU) 2023/1230 – often together with other legal acts, such as the Electromagnetic Compatibility Directive. The Low Voltage Directive plays a special role: its protection objectives also apply to machines, but the conformity assessment of electrical hazards is governed exclusively by the Machinery Directive, from 2027 by the Machinery Regulation. Only once this framework is established can it be assessed which requirements need to be met.

The risk assessment is the core. It determines which harmonised standards apply and what the technical file needs to demonstrate. At the end stands the EU declaration of conformity – the signature with which the manufacturer assumes responsibility. Only after that may the CE marking be affixed to the machine.

“The risk assessment determines which standards apply and what the documentation must demonstrate – whoever does it last is documenting a product they have not yet assessed."

The framework is changing – in stages

The legal framework is changing. The Machinery Directive 2006/42/EC is being replaced by the Machinery Regulation (EU) 2023/1230, which becomes binding from 20 January 2027. As a regulation, it takes effect directly in all member states, without national transposition. The basic structure of the seven steps remains – the details of the requirements change.

Important here: the regulation does not apply in full only from 2027. Under Article 54, Articles 26 to 42 have already been applicable since 20 January 2024, and Article 50(1) from 20 October 2026. Anyone running a project with a long development or delivery time needs to take the new requirements into account already now, because what counts is the placing on the market of each individual unit: a machine delivered from 20 January 2027 onwards must meet the Regulation, even if it was developed earlier (Article 3(12), Article 52(1)). And there is no transition phase in which either the old directive or the new regulation can be applied at will: until 19 January 2027 the directive applies, and from the 20th onwards, exclusively the regulation.

Our approach

For us, risk assessment and CE marking are part of product development, and the conformity documentation is part of the technical documentation. Both steps run alongside the development from the outset. If you would prefer to lead the process yourself, we set it up together with you in consulting: you create the documentation with AI support, and an engineer checks whether the result is technically sound and compliant with the standards. This reduces the effort involved without blurring responsibility.

This article provides an overview of the steps; it does not replace a case-by-case review and offers no guarantee of completeness.

---

Legal basis

1. Directive 2006/42/EC – on machinery (Machinery Directive), of 17 May 2006.
2. Regulation (EU) 2023/1230 – on machinery (Machinery Regulation), of 14 June 2023; applicable from 20 January 2027, Articles 26–42 already from 20 January 2024 (Art. 54).