The CE Mark is required for certain types of products to enter the “European Single Market,” also known as the European Economic Area (EEA). The European Single Market enables freer and more consistent trade among all 28-member states of the European Union (EU), and it has been extended in part to Iceland, Liechtenstein, Norway, and Switzerland.
The EU Single Market, which includes 500 million consumers and 21 million small to medium-sized businesses, uses the CE Mark to maintain high safety and environmental standards for imported products.
Once your product bears the CE Marking, it can be traded throughout the EAA without additional restrictions. However, its important to make sure your product truly requires the CE Mark because:
It is only required for products that fall under the New Approach directives.
The CE certification process can be complex and potentially costly.
Its illegal to affix the CE Mark to products that do not need it.
The New Approach directives lay out health and safety requirements that products must meet, but they dont go into specific technical details for each product type. Those details are left to European standards organizations (CEN, CENELEC and ETSI), which develop Europe-wide standards that align with the New Approach health and safety directives.
What Types of Products Need the CE Mark?
The European Commission does not publish a comprehensive list of products that require the CE Mark. Manufacturers, distributors, and compliance professionals must review the directives and determine which ones apply to certain products.
However, they do provide certain product categories that can help you decide whether or not the CE Mark is required. Your product will likely need CE Marking to export it to Europe if it falls into one of the following categories:
Cableway Installations Designed to Carry Persons, including funicular railways, cable cars, gondolas, chairlifts, and drag lifts. Regulation (EU) 2016/424 states that it applies to “cableway installations designed to transport persons used in particular in high-altitude tourist resorts, in urban transport facilities or in sports facilities.” If the cableway installation involves traction by cable and the ability to transport passengers, it typically requires the CE Mark.
Chemical Substances, including petrochemicals, polymers, basic inorganics, specialties, and consumer chemicals. The European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the current legislative framework for importing and exporting chemicals in the EU.
Construction Products refers to any product that will be permanently incorporated into construction works, including buildings and civil engineering products. The CPD and CPR lay out requirements for different types of construction products.
Electromagnetic Compatibility (EMC) refers to electrical and electronic equipment that has the potential to affect or disturb other electromagnetic devices. EMC directives are designed to minimize the “side effects” of these EMC technologies and make sure fixed EMC installations follow sound engineering practices.
Ecodesign requirements are designed to improve the environmental performance of household appliances, information technology, communication devices, and engineering technology. The Ecodesign Directive defines minimum requirements for energy efficiency of different types of products. Certain products may also require certain energy efficiency labels.
Equipment for explosive atmospheres, a.k.a. ATEX, defines requirements for products that operate in potentially explosive environments. This includes products used on offshore platforms, petrochemical plants, mines, and flour mills, among other locations.
Explosives for Civil Uses are subject to the Class 1 requirements of the United Nations recommendations on the transport of dangerous goods. These regulations cover thermal stability, safety features, measurement of toxic gases, detonation devices, and other aspects of civil explosives.
Gas-Burning Appliances, including any appliances and pressure equipment that use gaseous fuels to cook, heat, refrigerate, wash, produce hot water, or regulate water temperature. Pressure equipment and gas appliance directives go into more detail about the temperature and pressure threshold a product must meet to require CE Marking.
Low Voltage Equipment is defined as any equipment designed for a voltage between 50 and 1000 V for alternating current (A.C.) or between 75 and 1500 V for direct current (D.C.). The Low Voltage Directive (LVD) applies to most electrical equipment in everyday use.
Machinery refers to “an assembly of components, at least one of which moves, joined together for a specific application.” The Machinery Directive includes health, safety, and ergonomic guidance for machinery products being exported to or developed in the EU.
Medical devices regulations cover a very wide range of medical equipment, including everything from cloth bandages to advanced diagnostic equipment. Directive 93/42/EEC defines a medical device (MD) as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap;
investigation, replacement or modification of the anatomy or of a physiological process; or
control of conception.”
If you are exporting a medical product to the EU, make sure you review other medical device product categories as well. An “active implantable medical device” is designed to be introduced (either totally or partially) into the human body and remains in the body after the procedure, such as a pacemaker or a stent. An “in vitro diagnostic medical device” is designed to examine specimens from the body to help diagnose medical conditions, monitor treatment progress, and more. This could be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, depending on the product.
Personal Protective Equipment refers to products that are either worn or held to protect against hazards at home, at work, or during leisure activities. The personal protective equipment (PPE) directive defines design, manufacturing, and marketing requirements for protective equipment.
Radio equipment is covered by the radio equipment directive (RED), which outlines safety, health, electromagnetic compatibility, and radio efficiency requirements. These directives are designed to make efficient use of the radio spectrum, as well as avoid interference with other communications and signals.
Toys are regulated by the Toy Safety Directive 2009/48/EC. This directive outlines requirements to mitigate general riskshealth and safety of children, parents, and caregiversas well as physical, mechanical, flammability, chemical, electrical, hygiene, and radioactivity risks.
Note: This is not a comprehensive list of product categories that require the CE Marking. Refer to the New Approach Directives for more information about cosmetics, weighing instruments, pesticide equipment, lifts, packaging, pyrotechnic equipment, recreational craft, and more.