Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices


Therapeutic Products Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address locator: 3106B
Ottawa, Ontario
K1A 1B6

Notice to Industry / Avis à l'industrie

Licensing Requirements for Inter-dependent Medical Devices
Exigences pour l'homologation De matériels médicaux interdépendants

April 30, 2002

Purpose:

This notice is to remind manufacturers of their obligations under the Medical Devices Regulations when applying for medical device licences or Investigational Testing authorization, where these devices are intended to be used together or with other medical devices.

This situation arises when medical devices, used in conjunction with other medical devices, are licensed and sold individually.

An important requirement in demonstrating safety and effectiveness of all medical devices intended to be used together is compliance with Section 18 of the Regulations. Section 18 requires medical devices, intended to be used together with other medical devices, to be compatible with every other medical device with which it interacts and shall not adversely affect the performance of the combination of medical devices.

Failure to submit compatibility information for inter-dependent medical devices has led to delays in the pre-market review of device licence applications while the Medical Devices Bureau requests the necessary information and manufacturers assemble and submit it for review.

Manufacturers are therefore reminded that the submission of evidence of compatibility for inter-dependent medical devices is a requirement under the Regulations, in accordance with Section 18.

Pre-Market Requirements:

For a Class II medical device intended to be used with another Class II, III or IV medical device, this evidence should consist of:

  • a list of all licenced medical devices that the Class II device is intended to be used or function with, including their licence numbers.

For a Class III or IV medical device intended to be used with another Class II, III or IV medical device, this evidence should consist of:

  1. a list of all licenced medical devices that the Class III or IV device is intended to be used or function with, including their licence numbers.

  2. evidence of safety and effectiveness which demonstrates that the Class III or IV medical device is compatible with every other medical device with which it interacts and that it does not adversely affect the performance of the combination of medical devices. Evidence of safety and effectiveness of the assembled inter-dependent devices should include device specifications, pre-clinical testing, and clinical studies as appropriate.

Failure to provide this information with an application for a medical device licence or an application for Investigational Testing could result in the rejection of the application. The Bureau will not issue a medical device licence or an authorization for Investigational Testing unless all of the inter-dependent devices are authorized for sale.

Examples of system requirements are provided in the attached appendix. Should you have any questions or require further clarification relating to this notice, please contact the Licensing Services Division of the Medical Devices Bureau at (613) 957-7285.

Original Signed By:

Robert G. Peterson, M.D. PhD. MPH
Director General
Therapeutic Products Directorate


Examples:

The following examples are provided to illustrate licensing requirements when devices are intended to be used together but are licensed separately:

  1. Electrosurgical Generator, Cables, Handpieces and RF Tips


    The electrosurgical generator is a Class III medical device according to Rule 9(2) of the Classification Rules for Medical Devices. The cables, handpieces and tips are Class II medical devices in accordance with rules 7(2)(b) and 1(1) respectively.

    The Class II medical device licence applications must indicate the name of the electrosurgical generator these devices are intended to be used with, including the licence number(s) of the generator.

    The Class III medical device licence application must indicate the name of the cables and handpieces it is intended to be used with, including their licence number(s), along with evidence of safety and effectiveness which demonstrates that the generator is compatible with the cables and handpieces it interacts with and that it does not adversely affect the performance of the combination of medical devices.

  2. Cardiac Catheter Work Station (Console and Catheters)
    The console is a Class III medical device according to Rule 9(2) of the Classification Rules for Medical Devices. The catheters are Class IV medical devices according to Rule 1(2).

    The Class III medical device licence application for the console must indicate the name of the catheters it is intended to be used with, including their licence number(s), along with evidence of safety and effectiveness which demonstrates that the console is compatible with the catheters it interacts with and that it does not adversely affect the performance of the combination of medical devices.

    The Class IV medical device licence application for the catheters must indicate the name of the console(s) it is intended to be used with, including their licence number(s), along with evidence of safety and effectiveness which demonstrates that the catheters are compatible with the console(s) it interacts with and that it does not adversely affect the performance of the combination of medical.

  3. External Cardiac Defibrillator with Internal Leads
    The defibrillator is a Class III medical device according to Rule 9(2) of the Classification Rules for Medical Devices. The internal leads are Class IV medical devices according to Rule 1(2).

    The Class III medical device licence application for the defibrillator must indicate the name of the internal leads it is intended to be used with, including their licence number(s), along with evidence of safety and effectiveness which demonstrates that the defibrillator is compatible with the internal leads it interacts with and that it does not adversely affect the performance of the combination of medical devices.

    The Class IV medical device licence application for the internal leads must indicate the name of the defibrillator(s) it is intended to be used with, including their licence number(s), along with evidence of safety and effectiveness which demonstrates that the internal leads are compatible with the defibrillator(s) it interacts with and that it does not adversely affect the performance of the combination of medical devices.

  4. Surgical Stapler and Clips/Staples
    The stapler is a Class II medical device according to Rule 1(1) of the Classification Rules for Medical Devices. The clips/staples are either Class III or Class IV medical devices according to Rule 1(3) or 1(2).

    The Class II medical device licence application must indicate the name of the clips/staples the stapler is intended to be used with, including the licence number(s) of the clips/staples

    The Class III medical device licence application for the clips/staples must indicate the name of the stapler it is intended to be used with, including their licence number(s), along with evidence of safety and effectiveness which demonstrates that the clips/staples are compatible with the stapler it interacts with and that they do not adversely affect the performance of the combination of medical devices.
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