Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p42
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 42/43)
Character Range: 447754–450556

a malfunction or deterioration of a kind mentioned in subparagraph (i) that has led the manufacturer to take steps to recall system or procedure packs of that kind that have been distributed.
Note: See also paragraph 41FN(3)(d) and sections 41MP and 41MPA of the Act in relation to the requirement to give certain information about a medical device to the Secretary.

7.6  Records
 (1) The manufacturer must keep the statement and documentation required under the relevant clause of this Schedule in relation to a medical device to which the conformity assessment procedures in this Part have been applied.
 (2) The manufacturer must keep the statement and documentation for at least:
 (a) if the device is not an implantable medical device—5 years after the manufacture of the medical device to which the statement and documentation relate; or
 (b) if the device is an implantable medical device—15 years after the manufacture of the medical device to which the statement and documentation relate.
 (3) On request from the Secretary, the manufacturer must make the statement and documentation available to the Secretary.

Part 8—Clinical evaluation procedures

8.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device to obtain and evaluate clinical data in relation to the kind of device.
Note: See regulation 3.11 in relation to the kinds of medical devices to which these conformity assessment procedures must be applied.

8.2  References to kinds of medical devices
  A reference in this Part to a kind of medical device includes a reference to an individual medical device.

8.3  Obtaining clinical data
 (1) The manufacturer of a kind of medical device must obtain clinical data in relation to the device in the form of either or both of the following:
 (a) clinical investigation data in accordance with clause 8.4;
 (b) a literature review in accordance with clause 8.5.
 (2) The manufacturer must ensure that the clinical data obtained takes account of any medical device standard or conformity assessment standard that may apply to the device.

8.4  Clinical investigation data
 (1) For clause 8.3, clinical investigation data, in relation to a kind of medical device, includes:
 (a) documentation in relation to the design, approval, conduct and results of each investigation carried out by the manufacturer of the device in relation to the use of the device in or on a human body; and
 (b) a record of qualitative or quantitative information obtained through observation, measurement, tests 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