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Class III nIVD applications content and classification guidance: Clinical evidence

IMDRF common content and IMDRF Health Canada content may contain minor formatting or editorial edits compared to the source material. These changes were made to conform with the Government of Canada’s guidelines for web content.

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Chapter 4: Clinical evidence

Folder name: 4-CLINICAL

Note: No files or content should be included at this level. Only sub-folders of this folder should contain documents.

4.02 Overall clinical evidence summary

Folder name: 4.02-OverallClinicalEvidenceSumm

IMDRF common content

  1. This should be a brief (1 to 2 page) summary of the available clinical evidence being presented in support of the submission. The document should list the evidence presented, its characteristics (RCT, case study, literature review, post market data from another jurisdiction or from a marketed device) and provide a discussion of how this is considered sufficient to support request for marketing for the requested indications. A tabular listing of clinical studies may be included in this section
  2. If any of the study devices differ from the devices to be marketed, including competitor’s devices, a description of these differences and their impact on the validity of the evidence in terms of support for the application for any device referenced in the application. This may include a detailed comparison of the clinical, technical and biological characteristics of the two devices, with a detailed critical analysis demonstrating the devices to be similar to such an extent that there would be no clinically significant difference in safety or performance
  3. A discussion of the clinical evidence considered for the device and support for their selection (that is, what type of evidence was considered and why they were or were not used)
  4. Discussion to support why the evidence presented is sufficient to support the application 

Note: Human factors testing that include patients should be included here.

IMDRF Health Canada content

  1. Provide the Investigational Testing Authorization reference number for any clinical trials conducted under an Investigational Testing Authorization in Canada.
  2. If applicable, provide the clinicaltrials.gov reference number for any clinical studies registered with clinicaltrials.gov.
  3. Consult the guidance on clinical evidence requirements for medical devices for additional requirements.

Health Canada guidance

An evaluation of clinical evidence is necessary to help establish the clinical safety and effectiveness of a medical device for each claimed indication for use. A clinical evaluation considers available, relevant clinical data from published sources or device-related investigations. It may be necessary to generate additional clinical data to address specific issues for certain medical devices.

If a clinical history has been well established with a given device technology, evidence may be provided in the form of a literature review of relevant peer-reviewed scientific publications. Reference to devices other than the subject device in support of safety or effectiveness requires a thorough comparison to the subject device design, features and performance capabilities to demonstrate relevance. This may be provided in a table. Leveraged publications should be referenced but you only need to provide copies if they are pivotal in supporting safety or effectiveness.

Clinical evidence in the form of device-specific clinical investigations conducted in Canada or other countries should be summarized. Summaries should cover, clearly and meaningfully, the objectives, methodology and results presented in context. The conclusions on the outcome of the clinical investigations should be preceded by a discussion, with reference to the published literature. Both statistical and clinical significance should be considered and critically analyzed.

Classification

New and amendment applications: Conditionally required–  Not required when this type of evidence or testing is clearly not applicable to the device or submission. If scientific judgment is needed to justify why no information is required, then the heading is considered required and the justification should be provided.

4.02.01 Clinical evaluation report

Folder name: 4.02.01-ClinicalEvaluationReport

IMDRF common content

  1. A clinical evaluation report reviewed and signed by an expert in the relevant field that contains an objective critical evaluation of all of the clinical data submitted in relation to the device
  2. A complete curriculum vitae, or similar documentation, to justify the manufacturer's choice of the clinical expert

Classification

New and amendment applications: Optional

4.02.02 Device-specific clinical trials

Folder name: 4.02.02-DeviceSpecific

IMDRF common content

No content at this level. Clinical trial information under this heading should be grouped by trial.

Classification

New and amendment applications: Conditionally required – If any sub-headings are required

4.02.02.01 Trial description, protocol number, date of initiation

Folder name: 4.02.02.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

IMDRF common content

No content at this level

This heading should be custom and based on study details and created for each study under the parent heading. The sub headings below would be for this study alone. For example, the structure will look something like this

Level 3: EU Pilot Study, CT4203, 2010-10-10

Level 3: NA RCT Study, CT4584, 2011-01-23

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders, namely the summary and full report (when required) for the study presented. As described in the Health Canada Adapted Assembly and Technical Guide for IMDRF Table of Contents Submissions these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (that is, summary first followed by the full report second).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a pilot study and a controlled pivotal study are being presented, the application would include two subfolders:

As per IMDRF content guidance, the summary should contain:

Note: You should explicitly address any existing regional regulatory guidance related to the components of the clinical trial summary.

Classification

New and amendment applications: Conditionally required – Required for each study or test presented in this section

4.02.02.01.01 Clinical trial summary

Folder name: 4.02.02.01.01-Summ

IMDRF common content

  1. A summary of the specific study described in the custom heading above that includes:
    1. The key characteristics of the study (for example, title of study, investigators, sites, study period (date of enrollment/date of last completed), objectives, methods, number of patients, inclusion/exclusion criteria)
    2. Summary of the results of the analysis
    3. Summary of conclusions related to the endpoints

Notes:

  1. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the components of the clinical trial summary.
  2. The sponsor/applicant should explicitly state whether the data are sex-, gender-, age-, race-, and ethnicity-disaggregated. If the data are not disaggregated, the sponsor/applicant should provide a rationale why.

IMDRF Health Canada content

Consult:

Classification

New and amendment applications: Conditionally required – A comprehensive summary is required for each study or test presented in this section

4.02.02.01.02 Clinical trial report

Folder name: 4.02.02.01.02-TrialReport

IMDRF common content

  1. A clinical trial report of the specific study described in the custom heading above.

Notes:

  1. The clinical study report should include elements such as the investigational plan/study protocol, protocol changes and deviations, description of patients, data quality assurance, analysis/results.
  2. The sponsor/applicant should explicitly address any relevant existing regional regulatory guidance related to the components of the clinical trial report.

Classification

New and amendment applications: Conditionally required – A comprehensive full report is required for each study or test presented in this section

4.02.03 Clinical literature review and other reasonable known information

Folder name: 4.02.03-LitReview-OtherKnownInfo

IMDRF common content

  1. A critical evaluation of the relevant scientific literature currently available relating to the safety and/or effectiveness of the device. This should incorporate:
    1. A documented search protocol to a level of detail that allows the search to be reproduced
    2. A selection strategy (inclusion/exclusion criteria)
    3. Criteria for appraising the data (both favourable and unfavourable) to determine the contribution of each data set to support the conclusions;
    4. Results of the literature search
    5. A documentation of the appraisal to the extent that it can be critically reviewed by others
  2. A legible copy of key articles, including translation where applicable to meet the regulators language requirements

Or

  1. A statement that no literature related to the device was found

Notes:

  1. The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the clinical study and data provided in this section regarding the subject device.
  2. Please see Chapter 2.07 for post-market study plans.

Health Canada guidance

For more information on the use of scientific literature or published clinical data in support of the device safety and effectiveness, please refer to the clinical data and evaluation section of the Guidance on clinical evidence requirements for medical devices .

Classification

New and amendment applications: Conditionally required – When applicable to submission

4.05 Real world data

Folder name: 4.05-RWD

IMDRF common content

Include, where applicable, other clinical experience data/real world data (including device registries, post-market studies conducted in other jurisdictions).

Health Canada guidance

For more information on the use of real-world data and evidence in support of the device safety and effectiveness, please refer to the clinical data and evaluation section of the Guidance on clinical evidence requirements for medical devices .

Classification

New and amendment applications: Conditionally required – When applicable to submission

4.07 Other clinical evidence

Folder name: 4.07-OtherClinicalEvidence

IMDRF common content

Heading for other information that may be important to the submission but that does not fit in any of the other headings of this chapter.

Health Canada guidance

This section is specifically intended for studies performed to ensure the safety and/or effectiveness of the device that are not delineated in the rest of Chapter 4.

Applicants should also include an Overview.pdf file at the parent heading level of the relevant subchapter. This document should provide a concise summary (typically 1 to 2 pages) of both the IMDRF common content, and the IMDRF Health Canada content. In addition, the overview should include a brief rationale explaining how the submitted evidence supports the application.

Classification

New and amendment applications: Conditionally required – If any sub-headings are required.

4.07.01 Trial description, protocol number, date of initiation

Folder name: 4.07.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

Health Canada guidance

This folder should be customized to represent the details of the study. The contents of this folder should be limited to two subfolders, namely the summary and full report (when required) for the study presented. As described in the Health Canada Adapted Assembly and Technical Guide for IMDRF Table of Contents Submissions these subfolders are to be named to ensure the sequence remains as described in the IMDRF ToC (that is, summary first followed by the full report second).

Further, for each additional custom folder created, the final digit of the heading number should be incremented by 1.

For example, when a pilot study and a controlled pivotal study are being presented, the application would include two subfolders:

As per IMDRF content guidance, the summary  should contain:

Note: You should explicitly address any existing regional regulatory guidance related to the components of the clinical trial summary.

Classification

New and amendment applications: Conditionally required – This is required for each study presented in this section

4.07.01.01 Clinical trial summary

Folder name: 4.07.01.01-Summ

Health Canada guidance

The summary should contain:

Classification

New and amendment applications: Conditionally required – A comprehensive summary  is required for each study or test presented in this section

4.07.01.02 Clinical trial report

Folder name: 4.07.01.02-Report

Health Canada guidance

Include a clinical trial report of the specific study described in the custom heading above.

Classification

New and amendment applications: Conditionally required – A comprehensive full report is required for each study or test presented in this section

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2025-11-25