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/