CE Marking

CE marking (Conformité Européenne) is the mandatory conformity marking for products sold within the European Economic Area (EEA). Introduced by Council Directive 93/68/EEC in July 1993 and mandatory from January 1995, the CE mark indicates that a product meets EU health, safety, and environmental protection requirements. The marking covers products regulated by over 25 EU directives and regulations, including the Low Voltage Directive (LVD) for electrical safety, EMC Directive for electromagnetic compatibility, Machinery Directive, Radio Equipment Directive (RED), Medical Devices Regulation (MDR), Personal Protective Equipment (PPE) Regulation, and Toy Safety Directive. Unlike third-party certifications, CE marking is primarily a self-declaration process where manufacturers take responsibility for compliance.

The CE marking process involves identifying applicable EU directives, ensuring products meet essential requirements through harmonized European standards (EN standards), conducting conformity assessment procedures, compiling technical documentation, drafting an EU Declaration of Conformity (DoC), and affixing the CE mark. For over 90% of products, manufacturers can self-certify without involving a Notified Body. However, certain high-risk products (medical devices, pressure equipment, ATEX equipment) require third-party conformity assessment by accredited Notified Bodies listed in the NANDO database. Recent updates include new cybersecurity requirements under the Radio Equipment Directive effective August 2025, the new Machinery Regulation (EU) 2023/1230 applying from January 2027, and CE marking requirements for high-risk AI systems under the EU AI Act. Non-compliant products can be withdrawn from the EU market, and manufacturers may face penalties up to €40,000 or 4% of annual turnover depending on the member state.