Module A1 is one of the two variants of module A. Except covering design and production phase, part of the internal production control, it also includes supervised product testing. In comparison to module A, module A1 additionally has the following requirements:
- In order to ensure CE compliance, manufacturers or their representatives need to carry out at least one specific test on at least one particular product aspect for every other product that is individually manufactured;
- Depending on what the manufacturer chooses, the conformity assessment tests can be carried out by either an accredited in-house body or a notified body. The choice of the respective notified body also depends on the manufacturer.
- In case the manufacturer chooses to use a notified body for the conformity assessment procedures, the notified body can carry them out himself or supervise their execution. In either case, the notified body chosen must have adequate technical knowledge, experience and ability related to the conformity procedure.
- If by some chance the equipment for performing the assessment is situated with the manufacturer, all requirements on its suitability, functioning, maintenance, as well and measurement traceability have to be ensured and should be considered as part of the notified body’s responsibilities.
- If the manufacturer hasn’t applied the relevant harmonised standards, other tests equivalent to them must be carried out and validated by the notified body.
- In case the manufacturer chooses to go with an in-house assessment, the body performing the conformity assessment must be accredited. Moreover, the administration and double testing expenditures will be reduced, which can supposedly lead to reductions in the product’s final price for users and consumers.