Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p27
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 27/43)
Character Range: 409479–412275

the Secretary, or the person in relation to whom the kind of device is included in the Register, of any information of the kind mentioned in subparagraph 6.5(2)(c)(i) or (ii) that the manufacturer becomes aware of in relation to a kind of medical device.

6.4  Required technical documentation
 (1) The technical documentation must include adequate information in relation to the kind of device, and must include, in particular, the following:
 (a) a general description of the kind of device, and of any variants of the kind of device that the manufacturer plans to manufacture;
 (b) diagrams or drawings of the design of the kind of device, including diagrams or drawings of any components, sub‑assemblies or circuits of the kind of device;
 (c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the kind of device, to be properly understood;
 (d) if the kind of device is intended by the manufacturer to be supplied in a sterile state—a description of the method used to sterilise the kind of device;
 (e) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the kind of device;
 (f) if no medical device standard or conformity assessment standard has been applied, or a medical device standard or conformity assessment standard has been only partly applied, to the kind of device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
 (g) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the kind of device;
 (h) if the kind of device is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
 (i) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
 (j) a copy of the information to be provided with the kind of device.
 (2) If the manufacturer makes a change to the design or the production of the kind of medical device after the technical documentation has been prepared (for example, because it was necessary to apply corrective action in relation to the kind of device), the manufacturer must revise the technical documentation to take account of the change.

6.5  Post‑marketing system
 (1) The manufacturer of a medical device to which technical documentation prepared under clause 6.4 of this Schedule applies must establish, and keep up‑to‑date, a post‑marketing system that complies with