CE marking EU-compliant: the route to conformity assessment

What is a conformity assessment?

Conformity assessment is the systematic process by which a manufacturer demonstrates that their product meets the applicable EU requirements. In essence it is about closing the gap between the legal requirements (defined in EU directives and regulations) and the actual properties of the product, and documenting this.

A conformity assessment typically comprises:

The presumption of conformity: how harmonised standards help

A central concept of EU product legislation is the presumption of conformity. It works like this: if a manufacturer applies a harmonised standard that has been published in the Official Journal of the EU, their product is presumed to meet the corresponding essential requirements of the directive.

This presumption is rebuttable: a market surveillance authority can, in justified cases, demonstrate that the product does not meet the requirements despite the standard being applied. In practice, however, harmonised standards offer the safest and most efficient route to conformity.

Important: harmonised standards are voluntary in principle. The manufacturer can also choose other technical solutions but must then prove themselves that these achieve the same level of protection. In practice this is more laborious and riskier.

Self-assessment vs notified body: when do I need which?

Most manufacturers can carry out the conformity assessment of their machinery themselves. Only in certain cases must a notified body be involved.

The EU Declaration of Conformity: mandatory content

At the end of the conformity assessment process stands the EU Declaration of Conformity. With it the manufacturer declares in a legally binding way that their product meets all applicable requirements. The declaration of conformity must contain the following mandatory details:

The declaration of conformity must accompany the product (for machinery typically as part of the operating instructions) and be written in the official language of the country in which the product is made available. A copy must be part of the technical documentation.

Maintaining conformity over the life cycle

CE conformity is not a one-off act. Manufacturers must ensure that conformity is maintained over the entire production period. For series machinery in particular this is an organisational challenge:

Several directives at once: how do I proceed?

Most machines fall under several EU directives at the same time. A typical combination in mechanical engineering is:

For each applicable directive the specific requirements must be checked and met. The EU Declaration of Conformity must list all directives and regulations applied. The technical documentation must demonstrate conformity with each individual directive.

Article 3 of the Machinery Directive contains demarcation rules: if a hazard is regulated more specifically by another directive, the more specific directive applies to that aspect. For electrical safety, the Machinery Directive applies to machinery (it incorporates the protection objectives of the Low Voltage Directive); for EMC, the EMC Directive applies in its own right.

Conclusion: EU conformity is a process, not a document

The declaration of conformity is the visible result of a comprehensive process. Real EU conformity does not come from filling in a form but from a systematic, traceable conformity assessment that takes the entire product life cycle into account.

Consistent application of harmonised standards, a thorough risk assessment and complete technical documentation form the foundation. Whoever approaches this process in a structured way, ideally with the support of modern CE software, creates not only traceability but also safe products that earn customers’ trust.