Conformity assessment module D covers the examination of the conformity to type based on quality assurance of the production process (manufacturing and assessment of the end-product). Similarly to module C, it covers only the product’s production phase and follows module B.
The requirements specified in module C are presumed as fulfilled if the quality system, used for the examination, conforms to EN ISO 9001. The quality system, which shall determine whether the product complies with the type specified in the EC-type assessment certificate and all legislative requirements applicable to it, must be assessed by a notified body. If the final assessment is positive, then the manufacturer has to ensure and declare on his sole responsibility that the product is CE compliant.
Conformity assessment module D1 covers the quality assurance of the product’s production process, and it is a variant of module D. This module covers both design and production phases, but it is mainly concentrated on the latter one.
A specific aspect of module D1 is that it provides for the opportunity of using the advantages of module D but without the necessity of recurring to module B in the design phase. In other words, the manufacturer of a product, which design and construction are characterised with simplicity and low risk, is allowed to use a Declaration of Conformity instead of an EC-type examination certificate. This could further result in reductions of the manufacturer’s expenditures.
In comparison to conformity assessment module D, module D1 provides for additional provisions that contain other particular requirements. For instance, the manufacturer is obliged to draw up the product’s technical file. That is because there is no need for EC-type examination.
However, the similarity between both D and D1 is the necessity for an approved quality system for the control of the product’s production process. The quality system should conform to EN ISO 9001 if it is supposed to satisfy the module’s requirements. Moreover, the system should be operated by the manufacturer, but only after a notified body has positively assessed its compliance. Unlike in module D, here the quality system will have to ensure the product’s conformity with only the applicable legislative requirements.