CE (Conformité Européenne) marking is a regulatory conformity marking used within the European Economic Area (EEA) to demonstrate that a product complies with the applicable European Union legislation relating to safety, health, environmental protection, and other essential requirements.
Manufacturers are required to affix the CE marking to products covered by applicable EU legislation before they can be placed on the EEA market. Depending on the applicable legislation, this may require either a conformity assessment involving a Notified Body or a manufacturer’s self-declaration of conformity.
A single product may be subject to more than one EU Directive or Regulation. The CE marking itself does not indicate which legislation applies or which conformity assessment procedure was used. These details are documented in the EU Declaration of Conformity and the supporting technical documentation.
The CE marking is affixed by the manufacturer or its authorised representative—not by the Notified Body. It is the manufacturer’s responsibility to identify the applicable EU legislation and demonstrate compliance before placing the product on the market. More than twenty EU Directives and Regulations require CE marking for specific categories of products.
Our CE Certification Services
The Regulatory Management team provides comprehensive support throughout the CE conformity assessment process, including:
- Regulatory compliance assessment — identifying the applicable EU Directives and Regulations for your product and ensuring compliance with all relevant legal requirements.
- Technical documentation preparation — assisting in the preparation of technical files, product specifications, risk assessments, test reports, and other documentation required for CE marking.
- Testing and conformity assessment — coordinating product testing with accredited laboratories and, where required, supporting cooperation with the appropriate Notified Body.
- Audits and quality system assessment — assisting with the evaluation of manufacturing processes and quality management systems to verify compliance with applicable requirements.
- End-to-end CE marking support — guiding your organisation through every stage of the CE conformity assessment process, from the initial regulatory review to the lawful affixing of the CE marking.
- Post-market compliance support — assisting with post-market surveillance, ongoing regulatory compliance, and the resolution of product safety or conformity issues after the product has been placed on the market.
