CE marking is often informally called a “CE certificate”, but marking and certification are not the same concept in EU product law. The distinction determines the manufacturer’s responsibilities, the role of third parties and the documents that must be prepared.
At a glance
- CE marking is neither a quality mark nor approval of a product by an EU authority.
- It applies only to products covered by EU harmonisation legislation that provides for CE marking.
- The manufacturer is responsible for identifying applicable requirements and declaring conformity.
- Some legislation requires a notified body; other legislation may allow manufacturer assessment.
- Certification can be third-party confirmation under a defined scheme; it is not synonymous with CE marking.
What does CE marking mean?
By affixing the CE marking, the manufacturer takes responsibility for the product’s conformity with all applicable EU harmonisation legislation that provides for the marking and confirms that the required conformity-assessment procedures have been completed.
The mark does not indicate that the product was made in the EU, individually approved by an EU authority or entirely free of risk. Its meaning must be read together with the applicable legislation and completed assessment process.
Does every product carry the CE marking?
No. CE marking is used only for products covered by one or more items of EU harmonisation legislation that provide for it. It should not be placed on a product outside that scope.
A product may be covered by several EU acts. In that case, the CE marking represents conformity with all applicable acts that provide for it; the regulatory review should not stop at a single subject.
What does certification mean?
Certification is third-party confirmation that a product, process or system meets requirements under a defined scheme or standard. The legal basis, scope, certificate holder and surveillance conditions vary between schemes.
Certification may form part of a mandatory regulatory procedure or a voluntary quality or market programme. A certificate under one scheme does not automatically satisfy every rule that can apply to the product.
Key differences
| Topic | CE marking | Certification |
|---|---|---|
| Primary function | Indicates conformity with applicable EU harmonisation legislation | Third-party confirmation against a defined scheme or standard |
| Responsibility | The manufacturer retains ultimate responsibility | The certification body is responsible for its scheme assessment; the manufacturer remains responsible for the product |
| Application | Products within EU legislation that provides for CE marking | Mandatory or voluntary national, regional or private schemes |
| Third party | May or may not be required, depending on the legislation and procedure | Independent assessment is a defining element |
| Output | CE marking and the manufacturer’s EU Declaration of Conformity | A certificate, licence or conformity document as defined by the scheme |
The role of a notified body
Where the conformity-assessment procedure specified by EU legislation requires notified-body involvement, the body operates only within the legislation and scope for which it is notified. A body identification number on a product does not mean that it assessed every law applicable to that product.
The manufacturer remains responsible for product classification, identifying all applicable legislation, the technical file, production conformity and declarations.
How is the correct route determined?
- Define the product’s intended use and technical construction.
- Review all EU legislation that may apply.
- Determine the assessment route and third-party requirements under each applicable act.
- Prepare testing, risk assessment, technical documentation and user information.
- After the required assessments are complete, draw up the declaration of conformity and affix the CE marking.
Official sources
Related services
Product-specific scope, technical documentation and test requirements are confirmed at the start of each project.