Regulation 34

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 and storage of the medical device as are necessary to prevent the deterioration of the medical device while it is in the importer’s ownership, possession or control;

if the importer is the holder of an importer’s licence for the medical device —

must, if required under these Regulations, ensure, and maintain objective evidence to establish that, the handling and storage of the medical device complies with the requirements of the Good Distribution Practice Standard for Medical Devices or ISO 13485; and

must not use, for any purpose mentioned in sub‑paragraph (b), any premises other than the premises specified in the licence, or any other premises that the Authority may approve from time to time; and

must import only medical devices that are authorised to be imported by —

the registrant of the medical device;

the product owner of the medical device; or

any other person approved by the Authority.