Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 1
Character Range: 265037–265752

1  Use of medical devices not to compromise health and safety
  A medical device is to be designed and produced in a way that ensures that:
 (a) the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user or any other person, when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training; and
 (b) any risks associated with the use of the device are:
 (i) acceptable risks when weighed against the intended benefit to the patient; and
 (ii) compatible with a high level of protection of health and safety.