Regulation 33

must ensure, and maintain objective evidence to establish, that the medical device complies with the safety and performance requirements for the medical device set out on the Authority’s website;

must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the medical device as are necessary to prevent the deterioration of the medical device while it is in the manufacturer’s ownership, possession or control;

if the manufacturer is the holder of a manufacturer’s licence for the medical device —

must ensure, and maintain objective evidence to establish, that the manufacture of the medical device complies with the requirements of ISO 13485;

must provide and maintain such staff, premises, equipment and facilities as are necessary for carrying out, in accordance with the licence, the manufacture of the medical device;

must not carry out the manufacture of the medical device in any premises other than the premises specified in the licence;

must not use, for the purposes of handling or storing the medical device, any premises other than the premises specified in the licence, or any other premises that the Authority may approve from time to time;

must arrange, at the manufacturer’s own cost, for a testing laboratory approved by the Authority to carry out such tests as are necessary to ensure the safety, quality and performance of the medical device, and that the medical device complies with the safety and performance requirements for the medical device mentioned in paragraph (a); and

must, if the Authority requires in writing, furnish a copy of the results of the tests mentioned in sub‑paragraph (v) to the Authority within such time as the Authority may specify; and

must conduct all manufacturing operations in such a way as to ensure that the medical device is not wrongly labelled as another type of medical device.