Conformity Assessment Module A2

Module A2 is the second variant of module A. It covers both design and production phases, as well as supervised product checks at random intervals. In comparison to module A, module A2, similarly to module A1, specifies additional requirements. These requirements are as follows:

• The product checks at random intervals need to be carried out by either a notified body or an accredited in-house body. The choice is given once again to the product’s manufacturer. The random intervals are determined by the assessment body and are meant to verify the quality of the product, taking into account its technological complexity and the quantity of production.
• An examination of an adequate sample of the final product collected on-site by the assessment body must be carried out. Then, appropriate tests in accordance with what is stated in the relevant harmonised standards and/or technical specifications, or equivalent tests, must be carried out as well so that the product’s conformity with the applicable CE requirements can be confirmed.
• The sampling procedure is meant to determine whether the product’s manufacturing process is performed within acceptable limits and can ensure the product’s compliance. Usually, the appropriate tests, sampling schemes and operational characteristics of the statistical method are specified in the legislative instrument. All required corresponding actions shall be taken by either the manufacturer or the selected notified body.
• Similarly to module A1, the manufacturer could choose to proceed with an in-house assessment. Therefore, the administration and double testing expenditures will be reduced, which should lead to reductions in the product’s final price for users and consumers.