By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking. They are responsible for:

• Checking that their products meet EU safety, health, and environmental protection requirements. 

• Carrying out the conformity assessment

• Set up the technical file

• Issue the EU declaration of conformity, and affix the CE marking to a product.

Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.

6 steps to affix a CE marking to your product:

• Identify the applicable directive(s) and harmonised standards

• Verify product specific requirements

• Identify whether an independent conformity assessment (by a notified body) is necessary

• Test the product and check its conformity

• Draw up and keep available the required technical documentation

• Affix the CE marking and draw up the EU Declaration of Conformity 

Product groups:

• Active implantable medical devices

• Appliances burning gaseous fuels

• Cableway installations designed to carry persons

• Construction products

• Ecodesign of energy related products

• Electromagnetic compatibility

• Equipment and protective systems intended for use potentially explosive atmospheres

• Explosives for civil uses

• Hot-water boilers

• In vitro diagnostic medical devices

• Lifts

• Low voltage

• Machinery

• Measuring Instruments

• Medical devices

• Noise emission in the environment

• 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



Reference Documents

- Consulting to comply with RoHS

- CE mark in general

- Standards for mask

- Fabric mask - Requirement of European market

Contact us for more detail