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Conformity Assessment

Conformity assessment is based on the intervention of either the first party (i.e. the manufacturer) or a third party (Notified Body). The conformity assessment requirements are subdivided into eight Modules, numbered A to H. The Modules relate to the design or the production phase or both depending on the risk and consequential damages should a product fail. Each Directive describes the range and content of possible Modules that are applicable.

Modules D, E and H require that the manufacturer must have a quality assurance system in place. In this case, compliance with ISO 9001 confers presumption of conformity with the requirements of the Directives. The manufacturer is obliged in all cases to draw up a technical file that is intended to provide design, manufacture and operational information regarding each product.

In addition an EC Declaration of Conformity is required. This is drawn up by the manufacturer if resident in the EU, or by the resident Authorized Representative of a manufacturer outside of the EU. The EC Declaration of Conformity is a formal statement that the product meets all the essential requirement of the Directive. The EC Declaration of Conformity has to be kept for at least 10 years after manufacture should the authorities wish to scrutinize it.
see also
Check also from the consumers protection chapter;
Economic Development

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