A sponsor of a medical device must, within 30 working days of becoming the sponsor of the device,—
(a)
ensure that the information required to be entered in the database under these regulations is received by the Director-General or other person who maintains the database on behalf of the Director-General; and
(b)
provide to the Director-General or other person who maintains the database on behalf of the Director-General a declaration by the sponsor or an employee of the sponsor that complies with regulation 7.