Council Directive 93/42/EECShow full title

3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification.[F1 This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Directive and, in particular, those set out in Annex I.] It must also have access to the equipment necessary for the verifications required. U.K.

Textual Amendments

F1 Inserted by Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.