CE Marking – Product Certification

CE is an abbreviation for Conformite Europeenne, The CE Mark indicates that the product it is affixed to conforms to all relevant essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedure(s). The essential requirements refer, among other things, to safety, public health and consumer protection.

The CE Marking is not a quality-mark. It refers to safety rather than to the quality of a product. CE Marking is mandatory for the product it applies to, whereas most quality markings are voluntary. Many people use the term CE Mark. Initially, this was the phrase used to indicate this conformity marking. However, CE Mark was officially replaced by the term CE Marking in 1993. Thus, it is better to speak of CE Marking.

The technical documentation must allow assessment of conformity of the product with the requirement of respective directives. It must include:

  • A general description of the product including any variants planned.
  • Design, drawings, methods of manufacture envisaged, diagrams of the components, sub assemblies, etc.
  • Description and explanation necessary to understand above mentioned drawings, diagrams of operation of the products.
  • Save cost and time by avoiding duplication of effort, eliminating separate certification audits for individual customers
  • Result of risk analysis and list of standards referred description of solutions adopted to meet essential requirements of directives (if the standards are not applied in full).
  • In case of the products placed in the market in a sterile condition, description of the methods used. (If Applicable)
  • Result of design calculations and of the inspections carried out etc.
  • Test reports and where appropriate.
  • The label and instruction for use.
  • Operational Manual
In general the documentation must be made available until 5 years after the manufacture of last product to the national govt. of the country in which the product is placed on the market.