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Rules - MDD Implications of the DirectivesTo the manufacturers the Directives represent an advantage, but also an additional burden. When marketing products, the Directives will lead to an advantage with respect to the large EU market with a population of 400 million. However, the requirements for the products and manufacturing procedures have been tightened as regards design, production and control of the final product.The implications of the rules will vary relative to the size of the companies and thus small manufacturers, who have never operated in accordance with a quality system, will probably consider the rules very demanding. To users/hospitals the rules should imply that the purchasing of devices is simplified. When calling for bids, the minimum requirements for safety and performance may be considered fulfilled if the devices are CE-marked. Extensive questionnaires to the manufacturers should not be required since a notified body has already approved both the products and their manufacture. The adoption of the Directives also means that feedback systems, which will improve the quality of the products, are established. The feedback could result in corrective actions regarding the use and manufacture of existing products and the development of new medical devices. Back to index |
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