What are the directives that allow for CE Marking?
Not all New Approach Directives allow for CE marking . The Directives that allow CE marking are:
- Active implantable medical devices
- Appliances burning gaseous fuels
- 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
- Measuring instruments
- Medical devices
- Noise emission in the environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and telecommunications terminal equipment
- Recreational craft
- Safety of toys
- Simple pressure vessels
What should be the content of technical file?
Generally the technical file requires the following things:
- Description of the product
- Conceptual Drawing, Component Drawings etc
- Result of Risk Analysis
- Test Reports against applied Harmonised EN Standards
- Instruction for Use
- Signed Declaration of Conformity
Can you claim CE Marking without testing your product?
Annex IV of LVD Directive and EMC Directive and Annex VII of the Machinery Directive clearly asks for test report as a part of the Technical File.