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

On this page

• Safety and effectiveness requirements for Class III and IV medical devices
• What clinical evidence to submit
• When to submit clinical evidence

Safety and effectiveness requirements for Class III and IV medical devices

All Class III and IV medical devices must be safe and effective.

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

In addition to other safety and effectiveness studies, a manufacturer may submit clinical evidence to support the intended use of their medical device. The amount and detail of clinical evidence required depends on various factors (outlined below). This evidence is not required for Class II devices, but manufacturers should have this information available upon request.

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 varied groups of men, women and gender-diverse people (when applicable)

Manufacturers must also provide information on both:

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

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

• the device meets the requirements and
• the risk/benefit/uncertainty profile is acceptable

At the time of licensing, Health Canada may set out terms and conditions for tests 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

Summaries of clinical study should be submitted with all Class III and IV medical device licence applications. Full clinical study reports should also be submitted for Class IV medical device licence applications.

These requirements are in accordance with 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

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

When to submit clinical evidence

All medical devices must have objective evidence to support the claims of clinical safety and effectiveness. Some factors, however, will dictate whether device-specific clinical investigations may or may not be required in each case. Health Canada will assess each 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 applications of an established technology
• new or evolving safety or effectiveness issues with established technologies
• design modifications to established technologies
• new or uncommon indications for use (for example, in an application for amendment of a currently licensed medical device)
• new target population
• new intended user (for example, patient versus professional)
• medical devices designed for long-term implantation
• 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

Specific clinical data requirements are also identified through guidance or benefit-risk profiles for certain devices. Clinical Evidence Requirements for Medical Devices: Examples contains some examples of when clinical evidence is more or less likely to be required for different types of devices.

When device-specific clinical data are not required

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, if the evidence sufficiently addresses known risks and supports clinical intended uses.

Examples include the following:

• the impact of the subject device on the patient can be fully characterized non-clinically and its performance and safety is sufficiently well established to allow scientifically supported conclusions
• minor design modifications have been made to existing technology and either:
• 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 or
• the device has a well characterized incremental change from the previously licensed device, which is not expected to significantly affect its clinical performance, and the post-market performance of the previously licensed device is acceptable

In cases where clinical data are not required, a scientifically sound rationale should be provided within the application.

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