EU Product Conformity (CE) Certification

The CE mark is the MANUFACTURER'S declaration that the product meets the health, safety and environmental requirements of all EU legislation applicable to it. It is not a quality certificate or a certificate issued by a body; the mark is affixed by the manufacturer or its EU-based authorised representative. More than one piece of legislation can apply to a product, and all of them must be met.

• Manufacturers placing products on the EU and EEA market
• Those importing products from outside the EU and placing them on the market under their own name
• Firms modifying an existing product and selling it under their own brand
• Third-country manufacturers required to appoint an EU-based authorised representative

Mandatory for products falling under CE-scope legislation; they cannot be placed on the EU market without the mark. Affixing the CE mark to a product outside scope is prohibited and counts as misleading marking. Which legislation applies is determined by the product itself — this is the first and most critical step in the process.

• Determining the legislation applicable to the product (a product can fall within scope of more than one)
• Selecting the conformity-assessment module the legislation provides for
• Identifying harmonised standards and the presumption of conformity
• Carrying out the risk assessment and having the necessary tests done
• Preparing and retaining the technical file
• Drawing up and signing the EU Declaration of Conformity
• Affixing the CE mark to the form, size and visibility rules
• Economic operator obligations: manufacturer, authorised representative, importer, distributor
• Obligations towards market surveillance and inspection

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• UKCAUnited Kingdom Conformity
• ENECElectrical Product Safety
• GSGermany Product Safety
• S-MarkProduct Safety Mark
• ULNorth America Product Safety
• ETLNorth America Product Safety
• CSACanada Product Safety
• FCCRadio/EMC