Which products need it?
The CE marking is a product certification. CE mark on product signifies that a product has met EU health, safety, and environmental requirements, which also ensures consumer safety. CE marking is Mandatory for the Products, which are to be placed in EU countries.
If product is not CE marked it may be rejected at the port of entry. At present, 31 countries in EU ask for CE Mark and other countries are likely to ask for the same in the future. Product must comply with the Directive(s) and the Standards set by the European Union. One or more Directives may be applicable for the same product. Contact ICS to find out, which directives and standards are applicable to your products.
The products requiring CE marking include toy safety, medical devices, machinery, Electrical equipments, Radio and Telecom terminal equipment, Electronic Equipments, Pressure Equipments, Construction Products, Gas appliances, In vitro diagnostic devices, Lifts, Personal protective equipments etc. There are about 25 Directives requiring CE marking.
Before a manufacturer or importer is allowed to affix CE-marking on his product, there are a few steps to be undertaken by the Manufacturer or his authorized representative.
- Conformity Assessment Procedure:
1. Manufacturer performs the assessment
2. Manufacturer’s technical file
3. Manufacturer issues a declaration of conformity and affixes CE marking, BUT there is no Certificate.
- Third-Party Certification
1.CE notified / Competent body assessment
2 Manufacturer’s technical file with EC / Competent body report
3 EC/Competent body issues certificate and approval mark.
4 Declaration of conformity and affixing CE marking by Manufacturer
- Notified Body Certification
1 Examination by EC notified.
2 Assessment by EC body
3 Technical file with EC body report
4 EC body issues certificate and approval mark
5 Declaration of conformity and affixing CE marking by Manufacturer
- EC / Competent Body carries out:
1. Risk Assessment to verify that the product is safe to use and meets all requirements of the applicable directives.
2. Drawing up a Users Manual with instructions for safe usage and warnings for dangers
3. Drawing up a Technical File, content of which shows that the product meets all applicable
Certifications of CE MARK
New Approach Directives Which Needs CE Marking
|Product Name||The Related European Union Regulation||Directive|
|1. Low Voltage Devices||Low voltage equipment||(73/23/EEC)|
|2. Simple Pressure Vessels||Simple pressure vessels||(87/404/EEC)|
|3. Gas Appliances||Gas appliances||(90/396/EEC)|
|4. Hot Water Boilers||Hot water boilers||(92/42/EEC)|
|5. Electromagnetic Compatibility||Electromagnetic compatibility||(89/336/EEC)|
|7. Civil Explosives||Civil explosives||(93/15/EEC)|
|8. Non-automatic Weighingi||Non-automatic weighing instruments||(90/384/EEC)|
|9. Equipment and Protectiver||Equipment and protective systems intended for use in Potentially explosive atmospheres||(94/9/EC)|
|11. Pressure equipment||Pressure equipment||(97/23/EC)|
|12.Active implantable medical devices||Active implantable medical devices||(90/385/EEC)|
|13. Medical devices||Medical devices||(93/42/EEC)|
|14.In vitro diagnostik t?bbi cihazlar||In vitro diagnostic medical devices||(98/79/EC)|
|16. Recreational craft||Recreational craft||(94/25/EC)|
|17.Construction products||Construction products||(89/106/EEC)|
|18 . Personal protective equipment||Personal protective equipment||(89/686/EEC)|
|19. Radio and telecommunications terminal equipment||Radio and telecommunications terminal equipment||(99/5/EC)|
|20.Cableway installations designed to carry persons||Cableway installations designed to carry persons||(2000/9/EC)|