Why this is important to Wisconsin businesses: The marking indicates that a product has been assessed to meet the European Economic Area's standards for safety, health and environmental protection.
The letters “CE,” which appear on many products traded on the extended single market in the European Economic Area (EEA), signify that these products have been assessed to meet the EEA’s high standards for safety, health and environmental protection. When you buy a new phone, a teddy bear or a TV within the EEA, they all carry the CE mark. CE marking also supports fair competition by holding all companies accountable to the same rules. The mark is neither a quality mark nor a guarantee that the product meets all the requirements of the relevant EU safety legislation. It is, however, a visible sign that the product complies with relevant product supply law, and a presumption of conformity with product safety directives. European partners, distributors and importers will expect to see the CE mark in place or will want confirmation that an application is underway. CE-marked products are entitled to free movement throughout the EU/EEA.
CE marking applies to more than 20 product categories, ranging from electrical equipment and toys to machinery and medical devices. Obtaining the mark is the responsibility of the person who places the product on the market or puts it into service for the first time. In law, this duty rests with the Authorized Representative (AR) – usually the manufacturer. If the manufacturer is not based in the EU/EEA, the authorized representative is someone with a formal contract to represent the manufacturer in the territory; this may be an importer or distributor. There are six steps to attaining a CE marking:
- Identify the applicable directive(s) and harmonized standards.
- Verify whether the product meets those specific requirements.
- Check whether the product needs to be tested by a Notified Body.
- Test the product and check its conformity.
- Compile the technical dossier.
- Affix the CE marking and draft the EU Declaration of Conformity.
The technical file—which contains information on the design, construction, compliance assessment and product use—is essential to the process of demonstrating that the product complies with all applicable directives. This document should be in one or more official European Community languages, and should be retained for the time specified in the relevant directive.
The European Commission Declaration of Conformity (DoC) is issued by the manufacturer and accompanies all CE-marked products sold in the EU. Almost all new products supplied to the end user must include the DoC, which contains a product description, and a list of the applicable safety directives, among other information.
Additionally, industry-specific requirements exist for some types of products—such as machinery (European Directive on Machinery Safety) and electrical equipment (Low Voltage Directive). For medical devices, manufacturers of class-one devices and medical procedure packs must register with the relevant authority in the territory where they are based, as well as appoint an authorized representative.
More information can be found in the Blue Guide on the Implementation of EU Product Rules 2016.