CE Marking: how to declare product conformity

If you manufacture, import or distribute industrial, electrical, construction or personal-safety products within the European Economic Area (EEA), CE marking is probably not optional. It is the visible declaration that your product meets the essential requirements of the applicable European directive or regulation. In practice, however, we see the same pattern in many SMEs: the «CE» logo stuck on the product without anyone having drawn up the technical file or signed the declaration of conformity. That mistake can result in market withdrawal, a penalty from the market surveillance authority and, in the worst case, civil liability for damages.

This article explains exactly what CE marking involves, what steps must be taken to correctly declare conformity, and where your company can stumble if it handles the process without proper advice. If you want to assess your specific situation, our CE marking and declaration of conformity consultancy team can support you from the initial analysis through to signing the technical file.

What is CE marking — and what is it not?

The CE marking (Conformité Européenne) is the manufacturer's declaration that a product satisfies the essential requirements of the applicable European directives or regulations. It is not a quality seal, it does not certify that the product is «the best» nor that it has been audited by a notified body in every case. It is, above all, a technical-legal passport that allows free movement of the product within the EEA without member states being able to impose additional technical requirements.

What CE marking is not:

• A commercial brand or an indicator of consumer-perceived quality.
• A certification issued by third parties (although some products do require the involvement of a notified body).
• Equivalent to CE standards in other markets (China Export, for example, uses the same logo but has no connection with the European Union).
• A single procedure: each product category has its own directive or regulation with its own conformity assessment procedures.

Which products does CE marking affect?

Not all products placed on the European market need CE marking. Only those falling within the scope of one of the «new approach» (or «new legislative framework») directives or regulations that require it. The most common in the Spanish industrial landscape are:

The most significant development in 2025–2026 is the progressive entry into force of the new Machinery Regulation (EU) 2023/1230, which repeals Directive 2006/42/EC with mandatory application from 20 January 2027. Machinery manufacturers must start adapting their technical files to the new requirements now, as these incorporate specific criteria for machines with artificial intelligence functions and digital interconnection.

The CE declaration of conformity process: step by step

The generic procedure, with the particularities of each directive, follows this sequence:

1. Identify the applicable directives and regulations

A single product may fall within the scope of several directives simultaneously. A hydraulic press, for example, may be subject to the Machinery Directive, the LVD and the EMC at the same time. The first common mistake is assuming that only the «main» directive applies and ignoring the ancillary ones.

2. Determine the conformity assessment module

Each directive defines several assessment modules (from A to H) that establish whether the manufacturer can self-assess compliance or whether a notified body must be involved (an entity accredited by the member state, such as AENOR, TÜV, Bureau Veritas or SGS in Spain). Lower-risk products (module A) can declare conformity without third parties; higher-risk ones — PPE category III, machinery with elevated risk, class II and III medical devices — require an EC type-examination by a notified body.

3. Apply the harmonised standards

Harmonised standards are European standards (EN) published under the umbrella of the corresponding directive whose application creates a presumption of conformity with the essential requirements. They are not legally mandatory, but applying them is the safest and most documented way to demonstrate compliance. The list of current harmonised standards is published periodically in the Official Journal of the European Union (OJEU).

4. Draw up the technical file

The technical file (also called «technical documentation») is the heart of the process. It must include, at a minimum:

• General description of the product and its components.
• Design and manufacturing drawings, electrical diagrams, fluid-circuit diagrams.
• Description of the solutions adopted to meet the essential requirements.
• List of harmonised standards applied (in full or in part).
• Results of design calculations, tests and inspections carried out.
• Test reports, where applicable carried out by accredited laboratories.
• Instructions for use in the official language(s) of the destination country.

The technical file is not sent to any body unless the market surveillance authority requests it. It must be kept for a minimum of 10 years from the date the last product is placed on the market (the period varies by directive). In Spain, the competent market surveillance authority is the Directorate-General for Industry and Small and Medium-sized Enterprises (DGIPYME), under the Ministry of Industry and Tourism.

5. Draft and sign the EU declaration of conformity

The EU declaration of conformity (formerly called «EC declaration of conformity») is the formal document by which the manufacturer — or its authorised representative established in the EU — declares under its sole responsibility that the product satisfies the requirements of the applicable directives. It must contain:

• Name and address of the manufacturer (and authorised representative where applicable).
• Product description: name, model, serial number or batch.
• List of all directives and regulations applied.
• List of harmonised standards or other technical specifications applied.
• Where applicable: name, identification number and certificate of the notified body.
• Name, position, date and signature of the responsible person.

The declaration must be available in the official language of the country where the product is placed on the market. In the Spanish market, Spanish is mandatory.

6. Affix the CE marking to the product

The CE marking must be affixed to the product before it is placed on the market, in a visible, legible and indelible manner. If the dimensions of the product prevent this, it may be placed on the packaging and/or accompanying documentation. The format and minimum proportions of the logo are regulated (minimum height 5 mm unless the directive specifies otherwise). If a notified body was involved, its four-digit identification number must appear next to the CE marking.

New Machinery Regulation 2023/1230: what changes from 2027

Regulation (EU) 2023/1230, published in the OJEU on 29 June 2023, replaces Machinery Directive 2006/42/EC. Although its mandatory application begins on 20 January 2027, the transitional period is already active and manufacturers who wish to place products on the market in compliance with the new regulation from that date need to start adapting now. The most relevant changes are:

• New requirements for connected and intelligent machinery: the regulation introduces specific criteria for machines with machine-learning functions, interconnection and software updates. The technical file must document how risk is managed across the software lifecycle.
• Incorporation declaration for partly completed machinery: the new concept of «incorporation declaration» for partly completed machinery (components not functional on their own) is more demanding than before.
• Digitisation of the technical file: the file in digital format is expressly permitted and the declaration of conformity may also be issued digitally with a recognised electronic signature.
• Greater emphasis on cybersecurity: in line with the Cyber Resilience Act (CRA), machines with digital components must be protected against unauthorised modifications that could affect safety.

For machinery manufacturers in Castilla y León — a particularly important industrial sector in the region — this transition requires a thorough review of existing technical files and, in many cases, new risk analyses. At Summum Consultoría we support that process with a structured methodology and knowledge of the industrial sectors in the area.

Market surveillance and consequences of non-compliance

Regulation (EU) 2019/1020 on market surveillance and compliance of products strengthened the powers of national authorities to withdraw non-compliant products from the market. In Spain, the DGIPYME and the regional governments with industrial competences may:

• Order the immediate withdrawal of the product from the market.
• Prohibit commercialisation and require the recall of units already distributed.
• Impose financial penalties in accordance with the Industrial Safety Law (Law 21/1992) and the corresponding regional legislation.
• Publish the alert in the European RAPEX / Safety Gate system, which entails notification to all member states.
• In the most serious cases, report the matter to the public prosecutor for possible offences against worker or consumer safety.

The argument that «we did not know it applied» does not exempt the manufacturer or importer from liability. European legislation establishes that whoever places the product on the market is responsible for having verified compliance before doing so.

Importers and distributors: do they have obligations?

Yes. Regulation 2019/1020 and most «new approach» directives distinguish between manufacturer, importer and distributor, assigning obligations to each:

• Importer: a party that introduces into the EU market a product manufactured in a third country. The importer is responsible for verifying that the manufacturer has fulfilled its obligations (technical file, declaration of conformity, correct CE marking) before placing the product on the market. If the product does not comply, the importer is liable as if it were the manufacturer.
• Distributor: a party that distributes a product already placed on the market. The distributor must check that the product bears the CE marking and is accompanied by the required documentation in the language of the destination country. A distributor cannot distribute a product it knows to be non-compliant.
• Authorised representative: a natural or legal person established in the EU designated in writing by a manufacturer in a third country to act on its behalf in relation to all obligations under the directive.

Since 2021, Regulation 2019/1020 has also introduced the concept of the «responsible operator» in the most recent sectoral regulations: if there is no manufacturer established in the EU, the authorities may approach the importer or distributor to demand the technical documentation.

The most common mistakes we see in industrial SMEs

After more than fifteen years supporting industrial companies, these are the most frequent failures in CE marking management:

1. Affixing the marking without drawing up the technical file. The logo is stuck on the machine but no document backs it up. In a market inspection, the file must be available within ten days.
2. Using withdrawn harmonised standards. Standards are revised and old versions cease to provide a presumption of conformity from the date of withdrawal published in the OJEU. Many technical files still reference obsolete standards.
3. Failing to identify all applicable directives. An electrical machine must comply with MD + LVD + EMC as a minimum. Overlooking any one of them means the CE marking is technically false.
4. Incomplete or unsigned declaration of conformity. The document exists but lacks mandatory data or has not been signed by the authorised responsible person.
5. Failing to translate the instructions for use. If sold in Spain, the instructions must be in Spanish. If also sold in France or Germany, they must be in the local language. Many manufacturers only have the English version.
6. Modifying the product without updating the technical file. Any substantial modification to the design or components requires the risk analysis to be reviewed and, in many cases, new tests to be carried out.
7. Confusing CE marking with ISO certification. These are two different things with different objectives. ISO 9001 governs the management system; CE marking accredits the conformity of a specific product with essential safety requirements.

If your company is in any of these situations, the first step is a diagnosis of the current state of the existing technical files. Our CE marking advisory service includes that initial review, the identification of applicable directives and the action plan to regularise the technical file.

CE marking and the AI Act: the intersection ahead

The Artificial Intelligence Regulation (AI Act — EU Reg. 2024/1689), in progressive application since 2025, introduces conformity requirements for high-risk AI systems that overlap with CE marking. Specifically, AI systems integrated into products that already carry CE marking (machinery, medical devices, vehicles, etc.) must simultaneously comply with the requirements of the AI Act and the relevant sectoral directive. The declaration of conformity and the technical file must reflect both frameworks.

This represents a new challenge for manufacturers of machinery with adaptive numerical control, integrated machine-vision systems or robotic automation with learning capabilities. If your company manufactures or uses this type of equipment, it is advisable to review the dual-conformity strategy now. Our consultancy team coordinates this analysis together with the Summum IA specialists, who cover the technical aspects of the AI Act.

Frequently asked questions

How long does it take to obtain CE marking?

There is no administrative procedure that «grants» CE marking: it is declared by the manufacturer itself. The time depends on whether technical documentation already exists, whether laboratory tests need to be carried out and whether a notified body must be involved. A relatively simple product that does not require a notified body can complete the process in weeks if the documentation is well organised. A complex machine subject to multiple directives and requiring an EC type-examination may take several months, especially if appointments at the notified laboratory have to be awaited.

Is it mandatory to engage a notified body for CE marking?

Only in cases where the relevant directive requires it according to the applicable assessment module. For many products (low or medium risk category), the manufacturer can self-assess conformity and sign the declaration without third-party involvement. Involvement of a notified body — such as AENOR, TÜV Rheinland, Bureau Veritas or SGS — is mandatory, for example, for PPE category III, machinery with hazards listed in Annex IV of the Machinery Directive, or class II and III medical devices.

Does CE marking expire?

CE marking itself has no expiry date. However, it ceases to be valid if the harmonised standard used in the technical file is withdrawn from the OJEU (replaced by a new version) and the file is not updated to the new standard, or if substantial modifications are made to the product that have not been incorporated into the risk analysis and technical documentation. It must also be reviewed when a directive is updated or when a new regulation replacing it enters into force (as is happening with the Machinery Directive and Regulation 2023/1230).

What happens if I import a product from outside the EU that already bears CE marking?

As an importer, you are obliged to verify that the CE marking is legitimate: that the manufacturer holds the technical file, that the declaration of conformity exists and is complete, and that the product genuinely meets the essential requirements of the indicated directives. Blindly trusting that «the Chinese supplier has already marked it» without verifying the documentation is a legal risk that falls on the importer established in the EU. If during a market inspection the technical file does not exist or is incorrect, the authority may act against the Spanish importer as if it were the manufacturer.