Notified bodies for medical devices
Notified bodies are the auditing bodies for compliance with the general medical device requirements.
They are appointed by the national competent authorities, the AEMPS in Spain, who have the capacity to supervise the activities of these bodies, and they must provide them with all the necessary information, including that relating to the certificates issued, rejected, suspended or withdrawn.
The Ministry of Health and Social Policy shall designate the notified bodies that will carry out the procedures set out in the legislation applicable to the medical device, as well as the specific tasks assigned to each body, and shall notify the European Commission and the other Member States. Such designation shall be published in the Official State Gazette together with the identification number assigned by the European Commission and the specific tasks.
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