Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch3-7.2: Custom-made devices: prepare and supply with each device a signed statement identifying the device, patient, requesting health professional and design characteristics and confirming essential principle compliance or explaining departures, keep design and production documentation, and notify serious incident and recall information

What does sch3-7.2 require?

For each custom-made device the manufacturer must write a statement containing its name and business address, enough detail to identify the device or what the pack contains, a declaration that the device is meant only for one named patient or practitioner, the patient's name, the requesting health professional's name and business address, the design characteristics that professional specified, and a statement that the device meets the applicable essential principles or, if not, which principles are not met and why; the statement must be signed by an authorised person with name, position and date, and a copy must go with the device. The manufacturer must prepare and keep up to date documentation of design, production and intended performance, take all necessary measures to make the process produce devices matching it, and notify the Secretary promptly of failures, inadequacies or use that might lead or have led to death or serious deterioration, and of reasons for recall. Records are kept 5 years, or 15 years for implantable custom-made devices (clause 7.6).