The CE marking is one of the main indicators of a product’s compliance with European Union (EU) health, safety and environmental protection regulations.
If a product comes in the range of a directive requiring CE marking then the product must be in compliance with the applicable requirements and affix the CE mark before it is launched in the European Economic Area (EEA). This is valid even if your product is manufactured outside the EEA. Used products from outside the EEA that are placed in the EEA market for the first time, also require CE marking.
CE marking enables the free movement of products within the European market and hence at times described as a trade passport. As per the EU legislation, “the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark”.
Products that require CE Marking
· Simple pressure vessels
· Safety of toys
· Recreational craft
· Radio and telecommunications terminal equipment
· Pressure equipment
· Personal protective equipment
· Non-automatic weighing instruments
· Noise emission in the environment
· Medical devices
· Measuring instruments
· Low voltage
· In vitro diagnostic medical devices
· Household refrigerators and freezers
· Hot-water boilers
· Explosives for civil uses
· Equipment and protective systems intended for use in potentially explosive atmospheres
· Electromagnetic compatibility
· Eco-design of energy related products
· Cableway installations designed to carry persons
· Appliances burning gaseous fuels
· Active implantable medical equipments
Countries Where CE Marking Is Required
1. Austria (since 1995)
3. Bulgaria (since 2007)
4. Czech Republic (since 2004)
5. Cyprus (since 2004)
7. Estonia (since 2004)
8. Finland (since 1995)
12. Hungary (since 2004)
16. Latvia (since 2004)
17. Lithuania (since 2004)
20. Malta (since 2004)
22. The Netherlands
23. Poland (since 2004)
25. Romania (since 2007)
26. Slovakia (since 2004)
27. Slovenia (since 2004)
29. Sweden (since 1995)
30. United Kingdom (Great Britain)
31. Croatia (since July 1, 2013)
Switzerland though not a member of European Union, accepts CE marking for some of its products.
How to Get CE Marking
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements.
Minimal Risk: Product with minimal risk, can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. In order to self-certify, the Manufacturer must do several things:
1. Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product.
There are several modules available for the Conformity Assessment Procedures as listed below:
· Module A – Internal production control.
· Module B – EC type-examination.
· Module C – Conformity to type.
· Module D – Production quality assurance.
· Module E – Product quality assurance.
· Module F – Product verification.
· Module G – Unit verification.
· Module H – Full quality assurance.
Greater Risk: Products considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member State and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose its own notified body in any Member State of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.