Conformity Assessment Module A

Module A covers both design and production stages that are part of the internal production control. The module doesn’t require a notified body assessment but, on the other hand, manufacturers of products need to carry out all assessments required. The manufacturers’ primary responsibility is to ensure that their products comply with all applicable legislative requirements.

As mentioned above, there two phases: design and production. Each stage consists of two or more steps. In this regard, the design phase includes the following two steps:

• Identification of all applicable CE requirements;
• Execution of an adequate analysis and risk assessment.

As part of the production phase can be pointed out three steps:

• Manufacturers need to take all measures necessary for ensuring that all products manufactured conform with the legislative instruments applicable to them;
• They need to carry out detailed tests and controls;
• Consequence monitoring of the compliance of the respective products.