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EU conformity assessment routes: Module A, B, C and beyond

Which conformity assessment module applies to an Indian manufacturer, and when is a notified body required?

Answer

CE marking is the outcome; the module is the road you take to it. Union harmonisation legislation sets out the assessment procedures as lettered modules, and each product act names the modules a manufacturer may choose from. Module A is internal production control with no notified body. Module B is EU type-examination by a notified body, always paired with Module C, C1, C2, D, E or F for the production stage. Modules G and H cover unit verification and full quality assurance. The practical question is never whether you like a module, it is which modules your act permits for your product class.

What has to be done

  • Read the conformity assessment article of the act that governs the product, and list the modules it actually allows for your class; a module from another act is not available to you.
  • Module A, internal production control: you carry out the assessment yourself against harmonised standards, compile the technical documentation and sign the declaration. Most electromagnetic compatibility and low voltage electronics run here.
  • Module B, EU type-examination: a notified body examines the technical design of a representative sample and issues a certificate. It never stands alone; you pair it with a production-phase module.
  • Module C, C1, C2: conformity to the examined type. C is declaration by the manufacturer, C1 adds product testing, C2 adds supervised checks at random intervals by the notified body.
  • Modules D, E, F: quality assurance of production, of final product inspection, or product verification unit by unit or by statistics, each with a notified body in the loop.
  • Modules G and H: unit verification, and full quality assurance covering design and production with an approved quality system, which is where medical devices and higher-risk machinery land.
  • Choose the notified body from the Commission's NANDO list, and confirm it is designated for the exact act and annex you need; a designation for another directive is worthless for yours.
  • Keep the module in the declaration of conformity: naming the procedure and the notified body number is part of what makes the declaration valid.

Citations

Related requirements

Source and version

Sector
Electronics, machinery, medical devices, radio equipment
Read date
2026-08-26
Register version
in-export-v1.0.0
Address
/in/export/conformity-assessment

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