CE marking for non-EU manufacturers: step by step

The steps

1. Identify the legislation. Work out which EU directives and regulations apply to the product: mains voltage (Low Voltage Directive), electronics (EMC), radio (Radio Equipment Directive), hazardous substances (RoHS), batteries, toys, machinery, ecodesign and others. The product guides on this site show typical sets per product type.
2. Identify the essential requirements and the applicable harmonised standards. Harmonised standards cited in the Official Journal of the EU give a presumption of conformity with the requirements they cover.
3. Choose the conformity assessment route. Many consumer products can use internal production control (module A). Some need a notified body, for example certain machinery, toys not fully covered by harmonised standards, or drones in classes C1 to C3.
4. Test and assess the product. Test against the standards, in your own lab or an external one, and carry out a risk assessment. Test reports on components or modules support but do not replace assessment of the finished product.
5. Compile the technical documentation: description, drawings and circuit diagrams, risk assessment, test reports, the list of standards applied, and the documentation required by specific legislation. Keep it for 10 years.
6. Draw up and sign the EU Declaration of Conformity, listing all applicable legislation and the standards applied.
7. Affix the CE marking to the product (or its data plate), following the rules below.
8. Put an economic operator established in the EU in place and show its details on the product, packaging, parcel or accompanying document.
9. Prepare labelling and instructions: type and batch or serial number, your name and contact address, safety information and instructions in the language of each country of sale.
10. Complete the registrations that sit outside CE marking: WEEE and battery producer registration in each country of sale, packaging producer responsibility, and EPREL for energy-labelled products.

The EU economic operator: the step non-EU manufacturers miss

Under Article 4 of Regulation (EU) 2019/1020, a product subject to the main CE directives (including the LVD, EMC, RED, RoHS, Machinery, Toy Safety and Ecodesign legislation) may be placed on the EU market only if there is an economic operator established in the EU responsible for it. That operator can be a manufacturer established in the EU, an importer, an authorised representative with a written mandate, or, where none of those exists, a fulfilment service provider for the products it handles.

Its name, registered trade name or trade mark and contact details, including the postal address, must be on the product, its packaging, the parcel or an accompanying document. Customs can suspend the release of products without it. For consumer products outside CE legislation, the General Product Safety Regulation sets the same requirement in its Article 16.

Rules for the CE marking itself

• Affix it visibly, legibly and indelibly to the product or its data plate; only where that is not possible or not warranted, on the packaging and accompanying documents.
• Keep the official proportions, and a height of at least 5 mm unless the legislation specifies otherwise.
• Where a notified body is involved in the production control phase, its identification number follows the CE marking.
• Affix it before the product is placed on the market, and only if the product complies with all applicable legislation.
• Look-alike marks with different letter spacing or proportions are not CE marking, and CE marking on products not covered by CE legislation is itself an infringement.

Where non-EU manufacturers usually go wrong

• A test lab's "CE certificate" is treated as the CE marking. Labs test; only the manufacturer declares conformity.
• The declaration lists directives that do not apply (typically LVD for low-voltage products, or LVD and EMC next to RED).
• No EU economic operator, or one whose details do not appear on the product or packaging.
• Standards cited without year, or in versions no longer cited in the Official Journal.
• Instructions and warnings only in English or with machine-translated safety text.

Frequently asked questions