Home Arrow Icon Knowledge base Arrow Icon Global Arrow Icon What are the specific EU directives that CE marking adheres to


What are the specific EU directives that CE marking adheres to


CE marking indicates that a product conforms with EU safety, health, and environmental protection requirements[7]. It allows products to be traded freely within the European Economic Area (EEA), regardless of the country of origin[1]. CE marking is mandatory only for products with existing EU specifications[7][9].

The formal legal status of CE marking is detailed in various EU Directives and Regulations[1]. These directives and regulations are legislative acts adopted by the EU, considered "harmonized," and mandatory across all EU member states[3]. When a manufacturer affixes the CE marking to a product, it signifies that the product complies with all essential health and safety requirements from the applicable directives and regulations[1].

A few examples of EU directives that require CE marking[1]:
* Active implantable medical devices
* Appliances burning gaseous fuels
* Cableway installations designed to carry persons
* Construction products
* Eco-design of energy-related products
* Electrical and electronic equipment
* Equipment and protective systems intended for use in potentially explosive atmospheres
* Explosives for civil uses
* Fertilizers
* Hot-water boilers
* In vitro diagnostic medical devices
* Lifts
* Machinery
* Measuring instruments
* Medical devices
* Noise emission in the environment
* Non-automatic weighing instruments
* Personal protective equipment
* Pressure equipment
* Pyrotechnics
* Recreational craft
* Restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
* Toys
* Simple pressure vessels

Manufacturers must conduct a conformity assessment, create a technical file, and sign a declaration as stipulated by the relevant legislation before affixing the CE marking[1][3]. Importers must verify that manufacturers outside the EU have taken the necessary steps and that the documentation is available upon request[1]. Distributors need to demonstrate that they have acted with due care and have affirmation from the manufacturer or importer that the required measures have been taken[1].

Citations:
[1] https://en.wikipedia.org/wiki/CE_marking
[2] https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements
[3] https://www.trade.gov/country-commercial-guides/eu-eu-legislation-and-ce-marking
[4] https://www.cbi.eu/market-information/home-decoration-textiles/buyer-requirements
[5] https://www.gov.uk/guidance/ce-marking
[6] https://360compliance.co/ce-certification/
[7] https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
[8] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A32014L0031
[9] https://cemarking.net/eu-ce-marking-directives/