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Rules - MDD Who Ensures that the Requirements Are Fulfilled?The Directive concerning medical devices is based on the condition that the manufacturers to some extent assume the responsibility of complying with the requirements themselves. This is contrary to the medicines area where approval by the authorities is required before the product may be marketed.With respect to medical devices in class I, except from sterile devices and devices with a measuring function, it is the manufacturer alone who carries out the necessary evaluations. In the case of products in higher risk classes, the manufacturer must always have the design and/or the production of the medical device approved by an independent third party, a notified body, before the product may be CE-marked and marketed. Back to index |
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