CE Design Description

After successful completion of testing of product, we shall establish a technical documentation (Technical File) for the products to be covered for 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.
• 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.

The Technical file is reviewed for it’s adequacy in line to requirements of respective Directive