Products marketed within the European Union must fulfil and comply with European safety, health and environmental standards, regardless of whether they are manufactured outside the EU.
The CE marking is therefore compulsory for products for which EU specifications exist and which require the CE marking.
Whether we are talking about manufacturers or importers and distributors, the CE marking must be obtained and affixed to the products marketed.
Products covered by the mandatory labelling should fall into the following categories:
- Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Construction products
Ecodesign of energy products
Electromagnetic compatibility
Equipment and protective systems intended for use in potentially explosive atmospheres
Explosives for civil uses
Hot water boilers
In vitro diagnostic medical devices
Lifts
Low-voltage devices
Machine industry
Measuring instruments
Medical devices
Environmental noise measuring equipment
Non-automatic weighing instruments
Personal protective equipment
Pressure equipment
Pyrotechnics
Radio equipment
Recreational craft
Restriction of hazardous substances in electrical and electronic equipment
Safety of toys
Simple pressure vessels
For manufacturers, safety regulations do not require a licence to apply the CE marking. For example, taking the situation of selling hand-made toys online, a manufacturer should take the following steps:
Ensure compliance with all applicable EU requirements;
Determine whether they can assess the product themselves or whether they need to use a notified body
Draw up a technical file documenting the conformity;
draw up and sign the EU declaration of conformity.
The CE marking must be visible, legible and indelible, and may be affixed directly on the product, on the packaging or even on the documents accompanying the product. It must contain the initials 'CE' - both letters should have the same vertical dimension and be no smaller than 5 mm (unless otherwise specified in the relevant product requirements). The marking may be of different shapes and colours as long as the above indications are respected.
As far as importers and distributors are concerned, they have to verify and ensure that the manufacturer (even from outside the EU) has followed all the steps in order to place the products on the EU market. It is also necessary that the technical documentation and declaration of conformity are available to importers and distributors.
If importers or distributors commercialise the products under their own name, they take over the manufacturer's responsibilities. In this case, they should have sufficient information on the design and production of the product, as they will assume legal responsibility when applying the CE marking.