Medicines (Database of Medical Devices) Regulations 2003

the medical device or kind of medical device, as the case requires, in respect of which information is supplied, is a medical device or kind of medical device (within the meaning of these regulations) and is correctly classified in accordance with these regulations:

the medical device or kind of medical device, as the case requires, will only be recommended by the sponsor for use for its intended purpose:

the information supplied by, or on behalf of, the sponsor under regulation 6(a) is accurate and complete.