Entering the EU Market: CE Marking

The CE marking is the declaration of conformity with all the directives applying to a product for entry to the EU market. It is not a single certificate but the visible face of compliance with the totality of the legislation applying to the product.

The obligation lies with the manufacturer; for manufacturers outside the EU an authorised representative and, in the relevant product groups, a responsible person established in the EU come into play. The importer is obliged to verify the product's conformity and to add its own details.

• The list of directives applying to the product and the justification for the scope
• Test reports to harmonised standards
• Risk assessment
• Technical file
• The EU Declaration of Conformity
• A user manual in the language of the destination country
• Where a notified body is involved, the relevant certificate

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• A product can fall under several directives at once; all of them must be met
• Affixing CE to a product outside the scope is prohibited
• The technical file must be accessible within the EU
• If there is a radio module, RED replaces LVD and EMC

1. 01CE and UKCAThe essential requirements are largely the same; the distinction lies in the legal framework, the mark and the identity of the body involved. Test reports are mostly reusable and the declaration is renewed.
2. 02CE and EACBoth are regional conformity marks, but EAC requires the applicant to be established within the region and requires factory inspection for serial production. CE has no such concept of an applicant.
3. 03CE and quality certificatesSystem certificates such as ISO 9001 qualify an organisation's management system; CE declares the product's conformity with legislation. Neither is a precondition of the other and neither takes the other's place.
4. 04CE and voluntary product marksMarks such as GS and ENEC are voluntary and provide commercial confidence; CE is the legal condition of placing on the market. Holding a voluntary mark does not remove the CE obligation.

This page describes entry into the European Union market. The scheme itself — its scope, process, validity period and required documents — is covered in detail on the certification page.