CE Mark (EU Conformity Marking)

CE marking (Conformité Européenne) is the manufacturer’s declaration that a product meets the applicable EU New Approach directives or regulations and may be placed on the European Economic Area market. It is not a quality mark; it is a conformity statement covering health, safety, and environmental requirements specific to each product’s directive.

Scope

CE marking applies to products in scope of one or more of about two dozen New Approach directives and regulations: Machinery Directive, Low Voltage Directive, EMC Directive, Radio Equipment Directive, Toy Safety Directive, EU MDR, EU IVDR, RoHS, Pressure Equipment Directive, Construction Products Regulation, and others. Manufacturers compile a technical file, perform conformity assessment (self-declaration or notified-body involvement depending on risk class), affix the CE mark, and issue an EU Declaration of Conformity.

Relationships (see sidebar)

• Normative for the QMS (where required by the applicable directive), Classification Schema (directive scope per product), and the Document Vault (the technical file).
• Umbrella for EU MDR, EU IVDR, RoHS, and the other New Approach instruments.

Steward

European Commission and the relevant Member State market-surveillance authorities; conformity assessment is performed by notified bodies designated by Member States.