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Rules - IVDD Who Ensures that the Requirements Are Fulfilled?The Directive on in vitro diagnostic medical devices is based on the condition that the manufacturers themselves to some extent assume the responsibility of complying with the requirements.With respect to general in vitro diagnostic medical devices, except from devices for self-testing and devices in Annex II, it is the manufacturer alone who carries out the necessary evaluations. In the case of devices for self-testing and devices in Annex II, the manufacturer must always have the design and/or the production of the 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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