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
- GPSR Article 9: obligations of manufacturersArticle nodeOfficial text
- Cyber Resilience Act (EU) 2024/2847: assessment of products with digital elementsArticle node
- AI Act Article 43: conformity assessment of high-risk systemsArticle nodeOfficial text
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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