CEVerordnung

CE-Verordnung is a term used in German-language sources to refer to the European Union’s framework of rules that govern the CE marking, a conformity mark indicating that a product meets essential health, safety and environmental requirements for sale in the European Economic Area. There is no single binding regulation titled “CE-Verordnung”; rather, the CE marking arises from a set of EU directives and regulations that apply to different product groups.

The scope of the CE regime is broad and covers numerous product categories, including electrical equipment, machinery, toys, medical devices, personal protective equipment, construction products, and more. Each product category has specific EU directives or regulations (for example, low voltage directive, EMC directive, Toy Safety Directive) and may require conformity assessment by a Notified Body depending on risk class and category. Harmonized standards (European Norms, EN) provide presumption of conformity with the corresponding essential requirements.

Manufacturers are responsible for carrying out the conformity assessment, compiling technical documentation, and issuing an EU Declaration of Conformity. After meeting the applicable requirements, the product may bear the CE mark and be placed on the market within the EU/EEA. Importers and distributors also have duties to ensure ongoing compliance, proper labeling, and access to documentation.

Market surveillance of CE-marked products is conducted by EU member states and supported by Regulation (EU) 765/2008, which covers accreditation and monitoring of products entering the market. Non-compliant products can be withdrawn, recalled, or barred from sale, and penalties vary by country.