Investigator's Agreement in Accordance with Subsection 81(k) of the Medical Devices Regulations

Date: 2003-01-10

Device Name

Protocol Number

I,undertake, as outlined in Subsection 81(k) of the Medical Devices Regulations, to:

  1. conduct the investigational testing in accordance with the protocol:
  2. inform a patient who is to be diagnosed or treated with the device of the risks and benefits associated with its use and obtain the written consent of the patient,
  3. not use the device or permit it to be used for any purpose other than the investigational testing specified in the protocol,
  4. not permit the device to be used by any person other than myself, except under my direction,
  5. in the event of an incident that is related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use and has lead to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur, report the incident and the circumstances surrounding it to the Director and the manufacturer or importer of the device, within 72 hours after its discovery. (Tel: (613) 957-4587 Fax: (613) 957-7318)



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