Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p37
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 37/43)
Character Range: 435180–437882

applied must keep the following records in relation to the procedures and the kind of device:
 (a) the technical documentation mentioned in clause 6B.4 of this Part;
 (b) details of any changes made to the kind of device and to the technical documentation in relation to the design or production of the kind of device;
 (c) the declaration of conformity under clause 6B.6 of this Part;
 (d) details of any systematic review carried out, after production, in relation to devices of that kind.
 (2) The manufacturer must keep the records for at least 5 years after the manufacturer stops manufacturing devices of that kind.
 (3) On request from the Secretary, and within such reasonable period as is set out in the request, the manufacturer must make the records available to the Secretary.

6B.8  Notification of certain Class 4 in‑house IVD medical devices being manufactured
 (1) The manufacturer of a kind of Class 4 in‑house IVD medical device that the manufacturer intends to be used to detect the presence of, or exposure to, transmissible agents in blood, stool or other specimens from a person's body in order to assess the suitability of the person to be a donor of human stool for use in the manufacture of a faecal microbiota transplant product must notify the Secretary, in accordance with subclauses (2) and (3), about that kind.
 (2) A notification under subclause (1) must:
 (a) be in a form approved in writing by the Secretary; and
 (b) contain the information required by the form.
 (3) A notification under subclause (1) must be given to the Secretary:
 (a) if the manufacturer manufactures such a kind of Class 4 in‑house IVD medical device on or after the commencement of this clause and before 1 July 2021—no later than 20 working days after 1 July 2021; and
 (b) if, on or after 1 July 2021, the manufacturer manufactures such a kind of Class 4 in‑house IVD medical device—no later than 20 working days after the manufacture.
 (4) Only one notification is required under this clause in relation to each kind of Class 4 in‑house IVD medical device manufactured by a manufacturer.

Part 7—Procedures for medical devices used for a special purpose

7.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a medical device used for a special purpose:
 (a) to prepare a written statement containing certain information in relation to the device and to provide a copy of the statement with the device; and
 (b) to prepare and keep up‑to‑date particular documentation in relation to the device.

7.2  Custom‑made medical devices
 (1) This clause applies to a custom‑made medical device.
 (2) The manufacturer of the device must prepare