CE marking: what it means, which products need it, and how to apply it

What CE marking means — and what it does not

Regulation (EC) No 765/2008 sets the general principles in Article 30. The CE marking may be affixed only by the manufacturer or its authorised representative. It may be affixed only to products for which specific EU harmonisation legislation provides for it, and to no other product. By affixing it, the manufacturer takes responsibility for the product’s conformity with all applicable requirements of the legislation that provides for the marking. It is also the only marking that attests conformity with that legislation.

The letters are commonly said to stand for the French “Conformité Européenne”, but the legislation defines the mark by its function and its graphic form, not by an abbreviation. Its shape and proportions are fixed in Annex II of Regulation 765/2008. A logo that looks similar but means something else — the often-cited “China Export” story is one example of the confusion — does not attest anything, and marks likely to mislead third parties about the meaning or form of the CE marking are prohibited.

The CE mark is not a mark of quality or origin, and it does not mean that an EU authority has tested or approved the product.

Which products need CE marking

Only products covered by an EU act that provides for CE marking need it. A product can fall under several acts at once — a wireless smart toy can be covered by the toy, radio equipment, and RoHS rules — and the single CE mark then covers all of them. The notified-body column is a simplified orientation only; each act’s conformity assessment annex decides.

Self-declaration or notified body: the “CE certification” misconception

Many buyers ask suppliers for a “CE certificate”, and many search for “CE certification”. Neither term describes how the system works. CE marking is in principle a self-declaration: the manufacturer assesses the product, compiles the evidence, draws up the EU declaration of conformity, and affixes the mark. For a large share of everyday products — much consumer electronics under the Low Voltage, EMC, and RoHS directives, for example — that is the whole procedure, with no third party involved.

For higher-risk products, the act requires an independent conformity assessment body, called a notified body, to take part. A notified body may examine the design and issue an EU-type examination certificate, approve the manufacturer’s quality system, or verify products. Notified bodies are designated by EU countries for specific acts and tasks, and the Commission’s NANDO database lists each one with its four-digit identification number and the tasks it is notified for.

A laboratory test report is evidence, not a CE certificate, and even where a notified body is involved, the manufacturer still signs the declaration of conformity. When a supplier sends a “CE certificate”, ask for the signed EU declaration of conformity as well.

How to CE mark a product: the steps

The European Commission describes a six-step procedure for manufacturers. As a working sequence:

1. Identify every applicable act by checking each candidate’s scope and exclusions against the product’s function, power source, intended users, and features such as radio modules.
2. Identify the essential requirements and the harmonised standards that cover them, and record exactly which standards and editions you apply, in full or in part.
3. Choose the conformity assessment procedure from the modules the act allows, and decide whether internal production control is enough or a notified body must be involved.
4. If required, use NANDO to find a notified body for that act and module, and agree the scope of its examination, audits, or product checks.
5. Test the product and compile the technical documentation, including a risk analysis and test reports.
6. Draw up and sign the EU declaration of conformity. Use one declaration covering all applicable acts, following the model structure, and keep it with the technical documentation.
7. Affix the CE marking before placing the product on the market, followed by the notified body’s identification number where a notified body is involved in the production-control phase.
8. Re-assess when the product, its components, the standards, or the legislation change, and keep the documentation for the required period.

Conformity assessment modules A to H

Decision No 768/2008/EC defines the conformity assessment modules that sector acts draw from. Each act chooses which modules are available for which products, so the table explains the building blocks, not what your product must use. Module B is always combined with C, D, E, or F.

Technical documentation: what goes into the file

The technical documentation, often called the technical file, is the evidence behind the CE mark. Under the model in Decision 768/2008/EC it must make it possible to assess the product’s conformity and must include an adequate analysis and assessment of the risks. Wherever applicable, it contains at least:

• A general description of the product, including models or variants covered.
• Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and similar.
• The descriptions and explanations needed to understand those drawings and the operation of the product.
• A list of the harmonised standards or other technical specifications applied in full or in part; where harmonised standards were not applied, descriptions of the solutions adopted to meet the essential requirements; and, for partly applied standards, which parts were applied.
• Results of design calculations made and examinations carried out.
• Test reports.

The EU declaration of conformity and record retention

The EU declaration of conformity is the signed document in which the manufacturer states that the product meets the listed legislation and standards. Where several acts apply, Decision 768/2008/EC requires a single declaration covering all of them, identifying each act and its publication reference — not one declaration per directive. The declaration must be kept up to date and translated into the language or languages required by the Member State where the product is placed or made available.

The model modules require the manufacturer to keep the declaration together with the technical documentation for 10 years after the product has been placed on the market. Sector acts transpose this period, so confirm it in the act that applies. For the element-by-element contents and a fill-in template, see our guide to the EU declaration of conformity template.

Affixing the CE mark: size, placement, and notified body number

The affixing rules are the same across most acts, with variations where an act sets its own, so check the act before finalizing artwork and data plates.

Products that must not carry CE marking

Because Article 30(2) of Regulation 765/2008 limits the CE mark to products whose legislation provides for it, adding it to anything else is itself a breach. Common examples are general consumer products that fall only under the General Product Safety Regulation (EU) 2023/988, such as non-electrical furniture, clothing, cookware, or jewelry. Products with their own EU regimes that do not use CE marking, such as cosmetics and food, also must not carry it.

For GPSR-only products, the GPSR does not require an EU declaration of conformity or a CE mark. Instead the manufacturer carries out an internal risk analysis, draws up technical documentation and keeps it for 10 years, and ensures the product carries an identifier, the manufacturer’s details, and the instructions and safety information that apply to it. Where the manufacturer is not established in the EU, an EU-based responsible person is also needed.

Checks for importers, distributors, and online sellers

Importers and distributors do not affix the CE mark or sign the declaration, but they must not make non-conforming products available. Each sector act sets out what they must verify; in practice, a goods-in or listing review usually covers:

• The CE marking is present, correctly formed, at least 5 mm high, and followed by a notified body number where the procedure involved one.
• A signed EU declaration of conformity exists, names the exact model, and lists the acts and standard editions that fit the product.
• The manufacturer can provide the technical documentation to authorities on request.
• The product carries a type, batch, or serial number and the manufacturer’s name and postal address, plus importer details where the act requires them.
• Instructions and safety information are supplied in the language required by the Member State of sale.
• For acts listed in Article 4 of Regulation (EU) 2019/1020, an economic operator established in the EU is identified on the product, its packaging, the parcel, or an accompanying document.
• Online offers to consumers show the manufacturer, the EU responsible person where the manufacturer is not established in the EU, product identification, and the warnings or safety information that apply to the product.

CE marking at scale and in Great Britain

For teams checking documents from many suppliers, Doc2Shelf extracts identifiers, manufacturer details, and standards references from supplier PDFs into review-ready declaration drafts, flagging missing facts as [REQUIRED: …] placeholders. It does not assess conformity, test, or certify products; the manufacturer remains responsible for the declaration and the mark.

Great Britain still accepts CE marking for most product regulations: The Product Safety and Metrology etc. (Amendment) Regulations 2024 (SI 2024/696), in force since 1 October 2024, removed the end date for recognising CE. The UKCA mark remains an alternative, some sectors such as medical devices and construction products have their own rules, and Northern Ireland follows EU rules under the Windsor Framework. Our UKCA vs CE marking guide covers the details.