Class II Active Medical Device SYSTEMS and COMPONENTS


Hello everyone!

My company is pursuing a new medical device license (MDL) application for a Class II active medical device SYSTEM (essentially a stationary exercise bike with an integrated muscle stimulator for general rehabilitation). We've been going back and forth with the reviewers, and the following points have come up:
  • The guidance document for license application type says, "All the COMPONENTS of a SYSTEM must be listed on the licence application by MEDICAL DEVICE NAME and IDENTIFIERS. The application must provide documentation and information on all COMPONENTS of a SYSTEM."
  • Health Canada's definition of "medical device" includes an "accessory, part or component" in the definition, meaning all COMPONENTS of a medical device SYSTEM are defined as medical devices.
  • The guidance on device classification, Rule 7, says, "A device . . . is classified as Class II if it is intended . . . to be connected to an active device that is classified as Class II, III or IV."
All this seems to be indicating that (1) all components of a medical device are also considered to be medical devices, (2) all components of an active Class II device are also Class II, and (3) our license application needs to identify and include documentation for every component of the system. Is this an accurate assessment?

This seems extremely burdensome and is inconsistent with my prior MDL experience with an earlier generation of this device. I feel like I'm missing something, or the reviewer is, but I can't be sure. I'm hoping someone here can shed some light on the situation! Thanks in advance!



Not sure if this will help you but I assume they are looking 60601. What is the IEC 60601 Scope?

Are the "parts" you are talking about consumables or replacement parts?

I also thought that they may be using COMPONENT like 60601 (and the FDA) uses ACCESSORY, but it hasn't been made clear.

Our device does include consumables (disposable electrodes) which may be considered accessories, and technically any part of the device is "replaceable".

In our user guide, we point out major parts of the device, any of which could be replaced if needed. The reviewer asked, "Are the major parts of the device, listed your user guide, available for sale outside of the main unit? For example, if the console cable is damaged is the end user able to order a replacement of just the console cable?" My response was, "Yes, any part of the device may be considered for sale outside of the main unit in cases where the part requires replacement, including those major parts listed in the user guide. However, sales of device components are only made to existing device owners, and individual components of the device are not available for sale to the public, outside of the main unit. For example, if the console cable is damaged, the end user may order a replacement of just the console cable, but the console cable is not available for sale under any other context." They came back with the following:

"As you stated, the components of your device are available for sale (replacement parts) outside the main unit. As they are medical devices for sale, regardless of if they are available only to existing device owners, they still need to be compliant with the Medical Device Regulations. If they are class II medical devices then they are required to be licenced as well, and require their own labelling that is compliant with section 21(1) of the Medical Device Regulations. Please amend your application form to include these components and provide labelling. Please provide a classification rationale for each component, with reference to the Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs) for the classification rules."

Still very confused :unsure:
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