Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 3/43)
Character Range: 348186–350990

about a medical device to the Secretary.
 (3A) For the purposes of subparagraphs (3)(c)(i) and (ii), the information is the following:
 (a) information relating to:
 (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
 (ii) any inadequacy in the design, production, labelling or instructions for use of the kind of device, or in the advertising material for the kind of device; or
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
  that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in subparagraph (a)(i) that has led the manufacturer to take steps to recall devices of that kind that have been distributed.
 (4) Each requirement of the system must be documented in a systematic and orderly way in the form of written policies and procedures (for example, as quality programs, quality plans, quality manuals or quality records).
 (5) The documentation of the system must include adequate information in relation to the following matters:
 (a) the manufacturer's quality objectives;
 (b) the organisation of the manufacturer's business, including, in particular, a description of the following:
 (i) the organisational structure of the business;
 (ii) the responsibilities of managerial staff and their authority in relation to the quality of the design and production of medical devices manufactured by the manufacturer;
 (iii) the methods of monitoring whether the system is operating effectively, in particular, whether the desired quality of design and product is being achieved and how products that fail to meet the desired quality are controlled;
 (c) the design of the kind of medical device to which the system is to be applied, including, in particular, the following:
 (i) details of the processes, systems and measures used for controlling, monitoring and verifying that at each stage of the design process, the device complies with the applicable provisions of the essential principles;
 (ii) a general description of the kind of device, and of any variants of the kind of device, that the manufacturer plans to manufacture;
 (iii) details of the design specifications for the kind of device, including:
 (A) any medical device standard or conformity assessment standard that has been applied to the device; and
 (B) the results of the risk analysis carried out; and
 (C) if no medical device standard or conformity assessment standard, or part only of such a standard, has been applied to the device—the solutions adopted to ensure that each device complies with the