Medical Devices Regulations

61.4 (1) The holder of a medical device licence shall prepare

• (a) in the case of a Class II medical device, on a biennial basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 24 months; and

• (b) in the case of a Class III or IV medical device, on an annual basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 12 months.

(2) The information to be covered by the summary report is that in respect of

• (a) adverse effects;

• (b) problems referred to in paragraph 57(1)(a);

• (c) incidents referred to in subsection 59(1); and

• (d) serious risks of injury to human health that are relevant to the safety of the medical device and are referred to in subsection 61.2(2).

(3) The summary report shall contain a concise critical analysis of the information referred to in subsection (2).

(4) In preparing the summary report, the holder shall determine, on the basis of the critical analysis, whether what is known about the benefits and risks associated with the medical device has changed in any of the following ways:

• (a) the potential benefits for patients through the use of the device may be less;

• (b) in respect of each of the risks,

  • (i) the harm associated with the risk is more likely to occur, or

  • (ii) if the harm associated with the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and

• (c) a new risk has been identified.

(5) The holder shall include the conclusions they reach under subsection (4) in the summary report.

(6) If, in preparing the summary report, the holder concludes that what is known about the benefits and risks associated with the medical device has changed in any of the ways referred to in paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.