Information Sheet on the Application of Standards

The EU directives and regulations that require CE marking do not specify technical details but instead limit themselves to the essential requirements for safety and health protection. These legal provisions refer to harmonized standards for the specification of detailed technical requirements. Regulation (EU) 2012/1025 governs cooperation between European standardization organizations, national standardization organizations, the Member States, and the Commission for the development of European standards for products and services to support EU legislation.

The “New Approach” to technical harmonization dates back to 1985 and was amended in 2008 with the New Legislative Framework for the placing of products on the market. This legal framework also incorporates, among other things, the reference to standards. More than 30 EU directives and regulations fall under this new EU legal framework and apply to a vast number of products on the market. These include, among others, the EU directives on electrical equipment, pressure vessels, toys, machinery, and electromagnetic compatibility, as well as the EU regulations on personal protective equipment, construction products, medical devices, etc. (See also fact sheets on individual EU directives and regulations.) As an outward indication that the requirements of these regulations have been met, products must bear the CE marking.

The content provided is subject to German copyright law. Any reproduction, adaptation, modification, or use requires the written consent of the “European Standardization and Quality Assurance” Working Group. Where the content is subject to the copyright of third parties, it is identified as such.

These information sheets were compiled with great care. Nevertheless, no guarantee can be given as to the accuracy and completeness of the content.

Your Contact

Gerd Engelhardt
Gerd Engelhardt
Bayern Innovativ GmbH, Nuremberg
Patents & CE, Enterprise Europe Network

Stephan Helmprobst
Stephan Helmprobst
Bayern Innovativ GmbH, Nuremberg
Patents & CE