Guidance on clinical evidence requirements for medical devices: Submitting clinical evidence

Date published: November 15, 2022

On this page

• Clinical evidence requirements for medical devices
• What clinical evidence to submit
• When clinical evidence may be required
• When device-specific clinical data are not required

Clinical evidence requirements for medical devices

All medical devices must be safe and effective for their intended use(s).

Before issuing a medical device licence, Health Canada reviews licence applications to ensure that devices meet the safety and effectiveness requirements of the Medical Devices Regulations (Regulations). Sections 10 through 20 of the Regulations set out the requirements for the safety and effectiveness of medical devices in Canada.

In addition to other safety and effectiveness studies, a manufacturer may be required to submit clinical evidence to support the intended use(s) of their medical device.

Clinical evidence should demonstrate:

• the device is safe and effective when used as per the statement on indications for use and
• how the device affects diverse subpopulations, such as women and gender-diverse people, racialized minorities, pediatric and older populations (when applicable)

Manufacturers must also provide information on both:

• the risks and the benefits associated with using the device and
• the uncertainty associated with how accurately they can define the risks and the benefits of the device

Health Canada will issue a medical device licence if the application (and clinical evidence) demonstrates that:

• the device meets the requirements and
• the benefits of the device outweigh the identified risks and
• the uncertainties relating to the benefits or adverse effects associated with the device are not significant

At the time of licensing, Health Canada may set out terms and conditions to ensure a device continues to meet the safety and effectiveness requirements. (See "Additional obligations during post-market phase".) Once a device is on the market, Health Canada may also ask for information in order to determine if a licensed device continues to meet these requirements.

What clinical evidence to submit

Manufacturers of Class II medical devices must submit an attestation that they have objective evidence to establish that the device is safe and effective. This is set out in paragraph 32(2)(c) of the Regulations.

Manufacturers of Class III medical devices must submit a summary of all studies on which they rely to ensure that the device is safe and effective, and the conclusions that they have drawn from those studies. This is set out in paragraph 32(3)(f) of the Regulations.

Manufacturers of Class IV medical devices must submit clinical data on which they rely to ensure that the device is safe and effective. This is set out in paragraphs 32(4)(i) to (n) of the Regulations.

These requirements are in accordance with subsections 32(2), 32(3) and 32(4) of the Regulations and the following guidance documents:

• Supporting evidence to be provided for new and amended licence applications for Class III and IV medical devices
• Draft Health Canada IMDRF table of contents for medical device applications

During the application process, the Minister may request additional information and samples to determine whether a medical device meets the applicable requirements of sections 10 to 20. Thus, manufacturers should have this information available upon request.

For other requirements related to medical device licence applications, please consult applicable guidance documents.

When clinical evidence may be required

All medical devices must have objective evidence to support the claims of safety and effectiveness. However, some factors, will dictate whether device-specific clinical investigations may be required in each case. Health Canada will assess each new licence or amendment application based on the information provided, within the context of the indications for use, to support the safety and effectiveness of the device.

Device-specific clinical evidence may be required for the following:

• novel technologies
• less established technologies
• new safety or effectiveness issues with established technologies
• design modifications to established technologies (for example, any change related to performance characteristics, principles of operation and specifications of materials, energy source, software or accessories)
• new indications for use (for example, in an application for amendment of a currently licensed medical device) that cannot be fully supported by pre-clinical testing
• new target population
• new intended user (for example, patient versus professional)
• when the impact of the device on the patient, or the impact of the proposed device change on the patient, is:
  • not fully characterized by the non-clinical data available
  • irreversible (for example, the device cannot be removed once it is implanted (in situ))
  • variable (for example, the impact on the patient, the device configuration or user dependence can change)
  • invasive as defined in the Regulations
  • unknown

The companion document Clinical Evidence Requirements for Medical Devices: Examples contains some examples of when clinical evidence may be required for different types of devices.

When device-specific clinical data are not required

Device-specific clinical data may not be required if the evidence sufficiently addresses known risks and supports clinical intended uses. In that case, evidence supporting safety and effectiveness may be based on:

• clinical data that are not specific to a device or
• data that are specific to a device but not clinical in nature

Examples include the following:

• the ability of the subject device to perform as intended, safely and effectively, can be fully characterized non-clinically and its clinical performance is well established
• the subject device is an existing technology to which non-significant design modifications have been made and:
  • it has been demonstrated through pre-clinical standardized testing that the subject device meets standard pass/fail requirements or
  • the subject device has been shown to meet previously established and/or validated specifications
• an incremental change has been made to the device from the previously licensed device version, but the change is not expected to substantially affect its intended use(s) or clinical performance, and the post-market performance of the previously licensed device is acceptable

In cases where device-specific clinical data are not required, a scientifically sound rationale should be provided in the application. The rationale should justify that the available evidence sufficiently addresses known risks and supports clinical intended use(s).

Health Canada will review each application on a case-by-case basis. We will consider the evidence presented, its relevance to current Canadian clinical practice and the benefit/risk/uncertainty profile of the device.