The CE mark (for Conformite Europeen) is a symbol applied to finished products and machinery which meet applicable European directive. For electrical and electronic finished products, these include low voltage and, where relevant, Electromagnetic compatibility directive (EMC) directive.
CE Mark Self-Certification
CE Mark Self Certification is an option for some manufacturers, depending on their product. Some examples of product groups directives for which manufacturers can self-certify include:
- Safety of Machinery Directive
- Electromagnetic Compatibility (EMC) Directive
- Low Voltage Directive
- Class I products of the Medical Device Directive
- Most products covered by the Radio and Telecommunications Terminal Equipment (R&TTE) Directive
Conversely, the CE Mark does not allow manufacturers to self-certify in the following product group directives:
- Simple Pressure Vessels Directive
- Appliances Burning Gaseous Fuels Directive
- Most products covered by the Pressure Equipment Directive
- Most products covered by the Equipment and Protective Systems in Potentially Explosive Atmospheres Directive
Manufacturers who can CE Mark self certify must do the following:
- Decide whether the product needs to have a CE mark. If the product applies to more than one directive, it needs to comply with all of them.
- 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 Aa – Intervention of a Notified Body.
- 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.
CE Mark self certifying eligible manufacturers will still need to verify the standards by which their product must comply. Please note that the CE Mark might require compliance to more than one directive.
Manufacturers not permitted to CE Mark self-certify must work with a qualified testing lab such as Keystone Compliance. Keystone Compliance works with manufacturers to test and certify a product for the CE Mark.
Benefit of ce certification:
Your Product gets access to European Economic Area( 27 countries).
If all harmonised standards are applied,The product becomes SAFE and BETTER in QUALITY.
The product becomes more safe and visually more appealing
The Instruction for Use becomes more userfriendly.
Getting a Third Party Test Report against International Standards give you and your customer assurance of product quality.
Many other countries have signed Mutually Recognition Agreement with EU making CE a world wide mark demanded by importers worldwide.
Comprehensive risk assessment – improves your design process
To achieve ce certification:
- Find the CE directive(s) that apply to your product
- Know the essential requirements for your product
- Determine if you need third-party certification
- Assess product conformity
- Create and maintain technical documentation
- Declaration of Conformity & affixing the CE Mark