What are Module B and Module C?
Last reviewed 5 October 2026. Source: Regulation (EU) 2019/1009, consolidated text of 1 July 2026.
In simple words
Module B and Module C work as a pair. In Module B, an independent organisation called a notified body checks the design of your product. If the design is correct, it gives you a certificate. In Module C, you make sure that every product you make follows the approved design. Then you put the CE marking on it.
Words in this article
- Module
- One of the fixed routes for conformity assessment. The regulation has Module A, Module B followed by Module C, Module D1 and Module A1.
- Notified body
- An independent organisation that an EU country has approved to check products or quality systems. Some modules need one.
- Technical documentation
- The set of documents that show the product follows the rules. It includes the product description, the materials, the production process, test reports and the label.
- EU declaration of conformity (DoC)
- A signed document in which the manufacturer states that the product follows the rules.
- CE marking
- A mark on the packaging. It shows that the manufacturer states that the product follows the EU rules.
Module B: the application
You send an application to one notified body that you choose. You also state in writing that you did not apply to another notified body. The application contains:
- your name and address;
- the technical documentation;
- samples that represent your production;
- evidence that your design is suitable.
Module B: the result
The notified body checks the design and writes an evaluation report. If the design follows the rules, it gives you an EU-type examination certificate. If not, it refuses and explains why in detail.
Changes after approval
You must tell the notified body about changes that can affect compliance. Such changes need extra approval.
Module C
You make sure that production follows the approved design. You put the CE marking on each package and write the declaration of conformity. You keep the certificate, its annexes and the technical documentation for 5 years after the product is first sold in the EU.
What about the costs of the notified body?
The notified body charges its own fees. RecyFert's price for Module B followed by C does not include these fees. You pay them to the notified body directly.