Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p43
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 43/43)
Character Range: 450334–452720

or any other means used to assess the operation of the device; and
 (c) a written report by an expert in the relevant field, being a report that contains a critical evaluation of all the clinical investigation data held in relation to the device.
 (2) The documentation mentioned in paragraph (1)(a) must be in a form that allows the manufacturer to evaluate whether the device complies with the applicable provisions of the essential principles.
 (3) The record mentioned in paragraph (1)(b) must be in a form that allows the information in it to be independently assessed and verified.
 (4) If clinical investigation data is collected in Australia, the investigation must have been conducted in accordance with the ethical standards set out in the 'National Statement on Ethical Conduct in Research Involving Humans', published by the National Health and Medical Research Council, as in force from time to time.
 (5) If clinical investigation data is collected outside Australia, the investigation must have been conducted in accordance with the principles of the Declaration of Helsinki, as in force at the time and place where the investigation was conducted.

8.5  Literature review
  For clause 8.3, a literature review, in relation to a kind of medical device, includes:
 (a) a compilation, prepared using a documented methodology, of published literature and unpublished scientific literature, both favourable and unfavourable, relating to medical devices of that kind, including the following:
 (i) expert opinion;
 (ii) information about the hazards and associated risks arising from the use of the device for its intended purpose, and the foreseeable misuse of the device;
 (iii) information about the performance of devices of that kind, including a description of the techniques used to examine whether devices of that kind achieve their intended purpose; and
 (b) a written report by an expert in the relevant field, being a report that contains a critical evaluation of the compilation of literature mentioned in paragraph (a).

8.6  Evaluation of clinical data
 (1) The manufacturer of a kind of medical device must ensure that the clinical data is evaluated by competent clinical experts.
 (2) The manufacturer must ensure that clinical evidence demonstrating that the device complies with the applicable provisions of the essential principles is documented in writing.