CE marking

CE marking is a mark the manufacturer affixes to a product to declare that it meets the requirements of the EU harmonization legislation that applies to it and calls for the CE mark. It is not a quality mark or a certificate issued by an authority: the manufacturer demonstrates conformity and is responsible for it. The general principles are set out in Regulation (EC) No 765/2008, while the specific requirements come from the directives and regulations for each product group. The same rules apply across the European Economic Area, including to products made outside it, for example by US manufacturers.

CE marking only applies to products covered by at least one such piece of legislation. In mechanical engineering and electronics, the most common are the Machinery Directive 2006/42/EC, the Low Voltage Directive (LVD), the Electromagnetic Compatibility Directive (EMC), the Radio Equipment Directive (RED) and the RoHS Directive restricting hazardous substances. From 20 January 2027 the Machinery Directive is replaced by the Machinery Regulation (EU) 2023/1230. Medical devices, personal protective equipment, toys and pressure equipment, for example, have their own rules. Products outside all of this legislation must not carry the CE mark.

The manufacturer first identifies the applicable legislation and its essential requirements, carries out a risk assessment and designs the product to eliminate the risks or reduce them sufficiently. Conformity is usually demonstrated through harmonized standards (for example EN ISO 12100 for machinery risk assessment): meeting them gives a presumption of conformity, provided they are cited in the Official Journal of the EU. Depending on the legislation and the product category, the manufacturer either assesses conformity alone or must involve a notified body. Then come the technical documentation (often called the technical file), the EU declaration of conformity signed by the manufacturer, and affixing the mark.

The mark must be visible, legible and indelible and is generally at least 5 mm high. If a notified body was involved in production control, its identification number follows the mark. The manufacturer must keep the technical documentation available to market surveillance authorities, usually for 10 years after the product was placed on the market.

Plan for CE marking from the start of development, not just before launch. The requirements of the legislation and standards belong in the product requirements specification because they shape the design: guards and safety distances, safety functions of the control system, the IP rating, the choice of components, or the electronics layout for EMC. Pre-compliance tests, for example for EMC, are worth running on functional prototypes while changes are still cheap.

The obligation applies even to a single unit. A special-purpose machine built for in-house use must meet the same requirements as a series-built product. Partly completed machinery, intended to be built into another machine, is not CE marked under the Machinery Directive; it is supplied with a declaration of incorporation and assembly instructions.

A common mistake is treating CE marking as a certificate issued by a test lab. A test report is only supporting evidence: the manufacturer signs the declaration of conformity and bears the responsibility. Anyone who places a product on the market under their own name or trademark takes on the manufacturer's obligations, even if production is outsourced.

Other mistakes include an overlooked piece of legislation (a machine with a wireless module also falls under the RED), outdated versions of standards, a risk assessment written after the machine is already finished, and design changes made after the declaration was issued without a new assessment. Ask component suppliers for their declarations of conformity and check that they match your intended use.