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CE Marking Services Delhi

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Depending on product type and attestation level, the product must

  • be tested by a notified, accredited laboratory
  • be subject to a notified accredited product or factory control certification body.

The system that the manufacturer has to make use of document that the properties of the product comply with the harmonized EN standard or the European technical approval guideline (ETAG) is laid down in the European harmonized standards and the European technical approvals.

Step 1 Initial Type Testing
Step 2 Factory Production Control Manual (FPC)
Step 3 Factory Production Control in accordance with FPC Manual
Step 4 Internal Sampling and FPC Testing
Step 5 EC declaration of conformity
Step 6 EC declaration of conformity. Technical documentation
Step 7 CE Marking
Notified Body - one-off service
A Initial Type Testing
B Product (and FPC) Certification
B' FPC Certification
C EC Certificate
D Inspection
E Sampling of tests for external testing

CE MARKING Technical File

We shall arrange Testing of your products in Delhi, 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 CE Certification directives. It includes

  • 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 meeting requirements of CE Certification.

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