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NIST SP 951
ModulesModules are how conformity assessment procedures used in New Approach Directives are organized. Always articulated in the Directives, the modules describe the specific conformity assessment procedures to be applied to the products regulated by that directive. Modules vary in complexity. For example, Module A permits the manufacturer to assume total responsibility for conformity assessment. If the product is manufactured to Harmonized Standards, and if the risk is not unusually high (as in most machinery, for example), the manufacturer may rely on internal manufacturing checks. He or she compiles a Technical File, issues a Declaration of Conformity to the appropriate directives, and if appropriate, standards, applies the CE marking, and places the product on the market. Modules for active implantable medical devices, on the other hand, could call for a type examination of the product, plus a production quality assurance system that conforms to the ISO 9002 (EN 29002) standard. Another choice for a medical device manufacturer would be a complete quality assurance program that would conform to ISO 9001 (or EN 29001). Where the risk is high and/or where Harmonized Standards are not used, the modules will call for the involvement of a third party. In Europe, these third parties are designated by authorities and are called Notified Bodies. Each directive provides the module choices available, but there are no choices beyond the modules specified. Return to the Table of Contents
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