Conformity Assessment Module C2

Conformity assessment module C2 covers the examination of the conformity to type based on internal production control, along with supervised product tests at random intervals. Module C2, similarly to C1, is a variant of module C. Likewise, it covers only the production phase, and the product’s conformity is assessed against an approved EC-type resulted under assessment module B.

In comparison to module C, conformity assessment module C1 provides for additional provisions which, logically, contain more requirements. Such a requirement is that the conformity assessment body shall perform product checks or have them carried out at random intervals defined by the body. During the process, the product’s technological complexity and the quantity of production need to be considered. The manufacturer has the right to select the type of the institution that will carry out the assessment of the product and can choose between a notified body or an accredited in-house body.

When the assessment body has been selected, the same has to take, on-site, an adequate sample of the end-product and examine it. The product must not yet be placed on the single market. The examination includes appropriate tests through which the product’s compliance with the respective legislation is checked. These tests should be in accordance with what the relevant harmonised standard and/or technical specifications state. The described sampling procedure aims at determining whether the product’s production process is executed within the acceptable limits guaranteeing CE conformity. All possible appropriate tests, sampling schemes and actions, which an assessment body should undertake, are specified in the respective legislation.

Another similarity between module C2 and all other conformity assessment modules, allowing an in-house assessment body to perform the examination, is that the reliability of the tests is enhanced, as well as the level of product safety. The administration costs and double testing expenditures are also reduced, resulting in reductions of the product’s final market value.