Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_2
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 265752–266993

2  Design and construction of medical devices to conform with safety principles
 (1) The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art.
 (2) Without limiting subclause (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must:
 (a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and
 (b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and
 (c) third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and
 (d) fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.
 (3) In paragraph (2)(d):
residual risk, for a medical device, means the risk remaining after the measures described in paragraphs (2)(a), (b) and (c) have been applied.