The Member States of the European Union decided to lift trade barriers to stimulate mutual trade and to establish a common policy with non-EU countries. Thus, the single European market was created. One of the main obstacles was national requirements regarding, for example, product quality and safety. In order to allow the free circulation of goods, it was necessary to harmonize national systems in such a way that in every State Member, the requirements would be the same. So, the New Approach directives came to life. The directives state the basic safety principles for products to be placed on a single European market. The CE marking is the manufacturer’s declaration that the product complies with the directives. Below we list which products need CE marking.
When is CE marking mandatory?
The CE marking is required for:
- all new products manufactured in the Member States or third countries
- second-hand goods imported from third countries
- significantly modified products (which are thus subject to the Directives concerning new products).
The CE marking is mandatory and must be placed on the product before it is placed on the market. However, it only applies to specific product groups. In that case, what products must have CE marking? Such products are machinery, electrical equipment, toys, pressure equipment and gas appliances, personal protective equipment, and more. CE marking is placed, for example, on home appliances, mobile phones, lawnmowers, drills, computers, bicycle helmets, sunglasses, etc.
Which products must have CE marking?
A complete list of product groups for which the New Approach directives require CE marking:
- Appliances burning gaseous fuels
- Active implantable medical devices
- Cableway installations designed to carry persons
- Eco-design of energy-related products
- Electromagnetic compatibility
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Explosives for civil uses
- Hot-water boilers
- Household refrigerators and freezers
- In vitro diagnostic medical devices
- Low voltage devices/electrical equipment
- Measuring instruments
- Medical devices
- Noise emission in the environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio equipment
- Recreational crafts
- Toys for children under 14 years of age
- Simple pressure vessels.
Declaration of Conformity for products that need CE
Declarations of Conformity for different types of products usually have a similar layout; however, the information the documentation contains may differ. Sometimes the declaration must include a photo of the product (e.g., Declaration of Conformity for toys) or the last two digits of the year in which the CE marking for the product was issued for the first time (Declaration of Conformity for electrical devices) must be placed. In some cases, like in a Declaration of Conformity for machinery, the name of the person who is responsible for the technical documentation of the product must be provided. The New Approach Directive allows the CE marking to be replaced by another marking in some cases, e.g., the Marine Equipment Directive allows the placing of a steering wheel-shaped conformity mark instead of the CE marking.
If several directives require the placing of the CE marking on a given product, the manufacturer can place the CE marking only if the product meets all the requirements. Depending on the risk posed by the product and the regulations in the directives, various conformity procedures should be commenced.
Also, entrepreneurs who want to place on the EU extended Single Market or put into use products originating in non-EU countries, countries outside of the European Economic Area (EEA), or Turkey, must ensure that their goods meet the requirements of the New Approach directives. It should be remembered that the Declaration of Conformity and technical documentation of the product must be updated.
The CE marking and Declaration of Conformity only concern products sold within the EEA. If you import into other markets, you should get familiar with respective marks, e.g., FCC (in the US), EAC (Eurasian Economic Union), and CCC (China).