CE marking of machines

What is CE marking and what does it guarantee?

The CE marking is part of the European system of free movement of goods: instead of requiring national authorizations, the Union sets essential safety requirements that the manufacturer must meet under their own responsibility and demonstrate through a conformity assessment procedure. The letters CE are not a mark of quality or origin; they indicate that the manufacturer declares that the product complies with all applicable harmonized legislation (machinery, low voltage, electromagnetic compatibility, ATEX , pressure, among others) and assumes responsibility for this compliance.

In the case of machinery, the manufacturer must carry out a risk assessment in accordance with the principles of the UNE-EN ISO 12100 standard, design the machine applying the essential requirements of Annex I of the directive (integration of safety, controls, protection against mechanical, electrical and other hazards, maintenance, information), prepare the technical file, draft the instruction manual in the language of the country of use, issue the EC declaration of conformity, and affix the marking in a visible, legible, and indelible manner. Harmonized standards published in the Official Journal of the European Union provide a presumption of conformity with the requirements they cover.

For machinery listed in Annex IV of the directive (saws, presses, woodworking machinery, personnel lifts, protective devices, among others), the procedure requires EC type-examination by a notified body or a total quality assurance system, unless harmonised standards are fully applied. Partially manufactured machinery (intended to be incorporated into other machinery) does not bear the CE marking, but rather a declaration of incorporation and assembly instructions.

Obligations and documents

• Technical file. General description, plans, calculations, test results, risk assessment and measures adopted, standards applied, reports from notified bodies and copy of the manual and the declaration; available to the authorities for ten years.
• EC Declaration of Conformity. Signed document in which the manufacturer or their representative identifies the machine, declares its conformity with the directive and other applicable legislation, cites the harmonised standards used and, where applicable, the notified body.
• Instruction manual. In the official language of the country of use, with instructions for transport, installation, use, maintenance and dismantling, residual risks, required PPE, noise emitted and contraindications for use.
• Nameplate. Manufacturer’s name and address, machine designation, CE marking, series or model, serial number, year of manufacture and power data or other where applicable.
• Distributors and importers must verify that the machine has the required markings and documentation and must not sell non-compliant machines; the importer’s name must be on the machine or its documentation.
• Substantial modifications. Anyone who modifies a machine in such a way as to change its function or its level of safety, or builds a machine for their own use, assumes the obligations of the manufacturer and must follow the conformity procedure.

CE marking and prevention in the user company

• Presumption of conformity. Royal Decree 1215/1997 presumes that machines with CE marking comply with the minimum provisions of its Annex I, which does not exempt from evaluating suitability for the work and the place.
• Purchase verification. Check the existence and consistency of the marking, the declaration of conformity, the manual in Spanish and the plate; be wary of markings without documentation or with incomplete declarations.
• Installation and use. Follow the manufacturer’s instructions for installation, use and maintenance; unintended uses and modifications void the presumption of conformity.
• Older machines. Machines manufactured before the Machinery Directive do not bear the CE marking and must be brought into compliance with Annex I of Royal Decree 1215/1997 through documented technical assessment and adaptation, and are therefore not eligible for CE marking.
• Market surveillance. Market surveillance authorities may withdraw non-compliant machines; the user company must report any detected safety defects.
• Regulation (EU) 2023/1230. Introduces new rules on machines with artificial intelligence systems that affect safety, cybersecurity, digital instructions and a revised list of high-risk machines, applicable from January 2027.

Organizational application: how to manage CE marking in the company

1. Include in the machine purchase procedure the requirement for CE marking, declaration of conformity, manual in Spanish and nameplate, and verification by the prevention service before commissioning.
2. File the conformity documentation for each machine along with its record in the work equipment inventory.
3. Evaluate the suitability of the machine to the job and workplace in accordance with Royal Decree 1215/1997, without relying solely on the marking.
4. Control modifications: any functional or safety-related changes are analyzed before implementation and, if substantial, are submitted to the compliance procedure.
5. Manage old machines without marking through documented assessment and adaptation to Annex I.
6. Train purchasing, maintenance and production staff on the meaning and limitations of CE marking.
7. Follow the application of Regulation (EU) 2023/1230 for acquisitions from 2027 onwards, especially for machines with artificial intelligence and connectivity functions.

Preventive management software allows you to associate each piece of equipment with its declaration of conformity, manual and nameplate, control modifications and adjustments, and alert about equipment without conformity documentation.

Limits and common mistakes

1. Considering the CE marking as an absolute guarantee of safety in any use, omitting the risk assessment of the position.
2. Accept machines with markings but without a declaration of conformity, a manual in Spanish, or a technical file available.
3. Modifying machines (removing guards, changing functions, integrating into lines) without analyzing whether it becomes a substantial modification.
4. Marking CE on old machines that comply with Annex I of Royal Decree 1215/1997, which is not appropriate.
5. Confusing CE marking with quality certification or with the mark of conformity to voluntary standards.
6. Installing machines without following the manufacturer’s instructions, thus nullifying the presumption of conformity.

The essential requirements and procedures are detailed in Royal Decree 1644/2008 and Regulation (EU) 2023/1230; this sheet is for informational purposes.

Regulatory and reference framework

• Royal Decree 1644/2008, of 10 October . Rules for the marketing and commissioning of machinery (transposition of Directive 2006/42/EC).
• Regulation (EU) 2023/1230 on machinery . New European framework for the marketing of machinery, applicable from January 2027.
• Royal Decree 1215/1997, of July 18. Use of work equipment and presumption of conformity of equipment with CE marking.
• ISO 12100:2010 . Safety of machinery: General principles for design, risk assessment and reduction.
• Technical guide for the assessment and prevention of risks related to the use of work equipment (INSST) . Relationship between marketing and usage regulations.

The European Commission publishes the Guide for the application of the Machinery Directive 2006/42/EC and the lists of harmonised standards in the Official Journal of the European Union; the Ministry of Industry is the Spanish market surveillance authority in coordination with the autonomous communities.