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Class IV IVD 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 (1-2 page) summary of the available clinical evidence being presented in support of the submission. The document should list the evidence presented, its characteristics (for example well-controlled studies, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, 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 IVD medical devices differ from the IVD medical devices to be marketed, including competitors’ IVD medical 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 IVD medical 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.

If no clinical evidence is being provided, discuss why this is acceptable.

Health Canada guidance

The clinical performance studies used to establish the safety and effectiveness of the device should be presented to support the performance for each claimed indication for use.

The study protocol should include the testing algorithm, the population tested, the operator performing the test, the type of samples used, the site of the studies, the principal investigators, and a description of any panels used. A description of the statistical methods and rationale should also be provided.

The IVDD should be tested against a reference standard, method, or test, having a true clinical status, if known. If the reference is a commercial assay, it should have a valid Canadian licence, and the complete name(s) of the device(s) and the licence number(s) should be provided. If there is no Canadian licensed test, you are encouraged to contact the Medical Devices Directorate for further guidance.

Results from studies, conducted with samples representative of the specific population, under conditions similar to the conditions of use and conducted by the intended user, should be submitted in support of the clinical performance of the IVDD. These could include, for example, prospective studies conducted in a donor population, or in populations prevalent with a specific clade or strain of the agent.

Classification

New and amendment applications: Required

4.02.01 Expected values/reference ranges

Folder name: 4.02.01-ExpectedValues-ReferenceRanges

IMDRF common content

This section should include information on what values to expect in healthy normal patients versus affected patients.

Classification

New licence applications: Required

Amendment licence applications: Conditionally required – Not required if clearly not applicable to the amendment. If any rationale/testing/studies is conducted in support of the submission under the heading subject, this heading is required.

4.02.02 Clinical evidence evaluation report

Folder name: 4.02.02-ClinicalEvaluationReport

IMDRF common content

  1. A clinical evidence 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 IVD medical 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

4.02.03 IVD medical device specific clinical studies

Folder name: 4.02.03-DeviceSpecific

IMDRF common content

No content at this level

Clinical study information under this heading should be grouped by study

Classification

New licence applications: Required

Amendment licence applications: Conditionally required – If any sub-headings are required.

4.02.03.01 Study description, protocol #, date of initiation, date of completion

Folder name: 4.02.03.01-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 Controlled 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 (i.e. Summary first followed by the Full Report second).
Further, as described in the Health Canada Adapted Assembly and Technical Guide for IMDRF Table of Contents Submissions 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:

A custom folder named "4.02.02.01 -EU Pilot Study, CT4203, 2010-10-10" containing:

A custom folder named "4.02.02.02 -Pivotal Study, CT4558, 2012-12-10" containing:

Further guidance on the content of these files is provided in the headings that follow.

Classification

New licence applications: Conditionally required – This is required for each study/test presented in this section.

Amendment licence applications: Conditionally required -Not required if clearly not applicable to the amendment. If any rationale/testing/studies is conducted in support of the submission under the heading subject, this heading is required.

4.02.03.01.01 Clinical study summary

Folder name: 4.02.03.01.01-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, statistical design, interpretation of design, 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 study 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.

Health Canada guidance

For detailed information on summary content requirements and expectations, refer to the Definitions section of the Health Canada IMDRF Table of Contents for Medical Device Applications guidance .

Classification

New licence applications: Conditionally required – A comprehensive summary  is required for each study/test presented in this section.

Amendment licence applications: Conditionally required – Not required if clearly not applicable to the amendment. If any rationale/testing/studies is conducted in support of the submission under the heading subject, this heading is required.

4.02.03.01.02 Clinical study report

Folder name: 4.02.03.01.02-StudyReport

IMDRF common content

  1. A clinical study 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 existing regional regulatory guidance related to the components of the clinical study report.

Classification

New licence applications: Conditionally required – A comprehensive full report is required for each study/test presented in this section.

Amendment licence applications: Conditionally required – Not required if clearly not applicable to the amendment. If any rationale/testing/studies is conducted in support of the submission under the heading subject, this heading is required.

4.02.04 Clinical literature review and other reasonable known information

Folder name: 4.02.04-LitReview-OtherKnownInfo

IMDRF common content

  1. Clinical literature review that critically reviews available information that is published, available, or reasonably known to the applicant/sponsor that describes safety and/or performance of the IVD medical device
  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 IVD medical 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 IVD medical device
  2. Please see Chapter 2.07 for Post-Market Study Plans

Classification

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

Health Canada guidance

Include a discussion and a conclusion to support why the evidence presented is sufficient to support the application. If information within a publication is being submitted as key evidence of safety or effectiveness, a summary of the relevant data should be provided.

4.04 Investigators sites and IRB contact information

Folder name: 4.04-InvestigatorsSites-IRBContactInfo

IMDRF Health Canada content

List the clinical study sites including the name, description, and address.

Classification

New and amendment applications: Required

4.05 Real world data (RWD)

Folder name: 4.05-RWD

IMDRF common content

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

Classification

New and amendment applications: Optional

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.

Classification

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

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2025-11-25