Conformity Assessment Module E & E1

Module E covers the conformity assessment to a type used as a basis for the product quality assurance. Similarly to module B, the module focuses only on the product’s production phase. This module has three essential aspects:

• The quality system, used for the evaluation of the product’s conformity, has to be positively assessed by a notified body. The responsibility of the notified body here is to ensure that the system can guarantee the product’s compliance with the type described in the EC-type certificate and all the legislative requirements applicable to it.
• The manufacturer should be the one operating with the quality assurance system, used for the control of the final product’s inspection and testing.
• The manufacturer has the sole responsibility to ensure and declare that the product complies with what is stated in the EC-type examination certificate and the relevant legislative requirements.

Conformity assessment module E is not only similar to module B but as well to module D. Both B and D modules follow module B and are based on a quality assurance system that has to conform to EN ISO 9001. Despite the similarities, the final goal they pursue is what differentiates them significantly. Module D aims to ensure that the quality of the entire production process is according to the legislative provisions, while conformity assessment module B seeks to ensure the final product’s quality only. 

Module E1 (Quality assurance of final product evaluation and testing), a variant of conformity assessment module E, covers two phases: design and production. The main focus of the module, however, is on the production stage and the module itself aims to ensure the final product’s quality.

A similarity between module E1 and E is the necessity of operating a quality assurance system, approved by a notified body. All said earlier in regards to the quality system utilised in module E is valid here as well with the difference that the product’s conformity should be only ensured with the requirements of the legislative instrument applicable to it. In other words, there is no need of ensuring the product’s compliance with the type described in the EC-type examination certificate.

Module E1, except similar to module E, is also alike module D1 because it doesn’t require an EC-type examination certificate. Instead of such a document, the manufacturer is allowed to use the product’s declaration of conformity when it comes to products of a low risk, which design and construction have simplicity. Another similarity between modules E1 and D1 is that both provide for additional provisions. For instance, the manufacturer must draw up a technical file of the product.