Another conformity assessment module, which just like modules D and E follows module B, is module F (conformity to a type used as a basis for product verification). This module covers only the production phase and requires a notified body for the assessments.
The notified body is selected by the manufacturer and performs the third-party conformity assessment, which is meant to check and verify the product’s compliance with the type approved and described in the EC-type examination certificate. In addition to this, the product must also be proved as compliant with all of the relevant CE requirements.
Module F gives the product’s manufacturer some flexibility when it comes to the scope of the examination. For instance, the manufacturer can choose whether the study to include every product of the entire production or only some products on a statistical basis.
The way the examination is carried out is decided by the legislator. The latter determines, as follows:
- The products of interest
- The appropriate tests
- All adequate sampling schemes
- The operational characteristics of the statistical method
- All actions that the notified body and/or manufacturer should take.
Module F is similar to module C because both are based on product checks determining the product’s conformity with the EC-type approved. The only difference between both is that under module F these checks can only be performed by the notified body and not the manufacturer as it is in module C.
Upon a positive assessment, the manufacturer must declare his sole responsibility for the product’s conformity with the applicable legislative requirements and the type detailed in the EC-type certificate.