WHAT IS CE MARKING ?

• "CE" marking is the Symbol

• CE is the abbreviation of "Conformité Européene" meaning "European Conformity"

• Implies manufacturer’s declaration of conformance of essential requirements with all European directives

• Is a "Passport to Europe"

• Is a "Symbol of Quality."

• Is not a product quality standard

NEED FOR CE MARKING

• Required to export to 15 European Union(EU) and 3 EFTA member states for 23 groups of products.

• CE mark ensures that product placed on the EU market are safe as they follow the laws, regulations and administrative provisions as per directive requirement.

• CE Marking is a measure that the EU has adopted to establish single market and foster economic development for the member states 

• Indicates that the product may be legally placed on the market in EU countries.

• Ensures the free movement of the product within the EU single market

NOTIFIED BODY

• Is a certification organization which the national authority (The Competent Authority) of a member state designates to carry out the conformity assessment procedures.

E.g.: SGS, National Quality Assurance Ltd, Lloyd’s Register Quality Assurance Ltd, Bureau Veritas Quality International Ltd.

THE PROCESS OF CE MARKING FOR MD’S

• Determine whether the product is within the scope of the directive

• Identify the device classification

• Select a notified body based on classification

• Notified body to confirm the classification

In case of disagreement on classification decision to be obtained from Competent Authority/ EC commission

• Select the conformity assessment routes

• Compliance to essential requirements of the directive

• Preparation of technical file

• EC declaration of Conformity

• Assessment of compliance of requirements by Notified body

• Issue of certification

• CE marking