CE marking is a mandatory conformity marking for products covered by EU harmonisation legislation. The CE mark indicates that a product complies with all applicable EU directives and regulations and can be placed on the EU market. CE marking is required for: toys; electrical equipment; machinery; medical devices; personal protective equipment; construction products; and many other product categories.
Conformity Assessment Procedures
The conformity assessment procedure for CE marking depends on the product category and the applicable EU legislation. For low-risk products, manufacturers can self-certify by conducting an internal production control (Module A). For higher-risk products, third-party conformity assessment by a Notified Body is required. The applicable module is specified in the relevant EU directive or regulation.
Declaration of Conformity
Manufacturers must draw up an EU Declaration of Conformity (DoC) before affixing the CE mark. The DoC must contain: the product identification; the name and address of the manufacturer; a statement that the product complies with all applicable EU legislation; reference to the applicable standards or technical specifications; the place and date of issue; and the signature of the authorised representative.