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Rules - IVDD Requirements for the ManufacturersThe natural or legal person responsible for the design and manufacture of the product and who markets the product in his own name is defined in the Directive as the manufacturer, regardless of whether these operations are carried out by himself or on his behalf by a third party.All the requirements in the Directive relate to the manufacturer when it comes to the products' fulfillment of the "Essential Requirements", preparation of technical documentation and risk analysis, clinical data, safe reproduction of the medical devices and incident reporting. Back to index |
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