Class III IVD applications content and classification guidance: analytical performance and other 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.

Chapter 3: Analytical performance and other evidence

Folder name: 3-ANALYTICALPERF

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

3.05 Analytical performance

Folder name: 3.05-AnalyticalPerf

IMDRF common content

No content at this level.

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

Health Canada guidance

Manufacturers must justify their chosen study design for the appropriate sub-chapter. This can be achieved by clearly indicating the use of standards in premarket submissions and appropriately identifying any referenced standards in their Premarket Review Submission. If the study design deviates from Health-Canada recognized standards, clear justifications should be provided.

Manufacturers opting for alternative study designs should include a rationale supporting the validity of their approach.

Classification

New licence applications: Required

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

3.05.01 Stability of specimen(s)

Folder name: 3.05.01-StabilityofSpecimens

IMDRF common content

Information regarding and studies to support the stability, storage and where appropriate, transport, of all of the specimen type(s) identified in the labelling, including any and all recommended additives (for example anticoagulants) is to be provided in this section. This should include:

For each specimen type identified in the labelling, a description of the recommended storage parameters and when applicable, transport conditions (for example duration, temperatures and freeze/thaw cycles)
A justification on the selection of the studies performed
Provide summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A discussion of why this category of study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject device.

Classification

New licence applications: Required

Amendment licence applications: Conditionally required – Not required when this type of evidence or testing is 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.

3.05.01.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.01.01-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: Storage of serum samples for 7 days at 2-8ºC or 4 days at -20ºC.
- Level 4: Summary
- Level 4: Full Report
Level 3: Validation of 3 freeze/thaw cycles for serum samples
- Level 4: Summary
- Level 4: Full Report

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 storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.01.01.01 Summary

Folder name: 3.05.01.01.01-Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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 and amendment applications: Conditionally required: A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence.

3.05.01.01.02 Full report

Folder name: 3.05.01.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.02 Validation of specimen

Folder name: 3.05.02-ValofSamples

IMDRF common content

Studies to support the validity of specimen type(s) used in the analytical and clinical studies as representative of all of the sample type(s) identified in the labelling, including any and all recommended additives (for example anticoagulants), as well as contrived specimens used in certain analytical studies are to be included in this section. This should include:

A list of the specimen type(s) used, including any additives (for example anticoagulants), in each of the analytical performance studies. If the same specimens are used for all analytical studies this can be stated and the specimen type identified
For any or all of the analytical and clinical studies, if a particular specimen type(s) including additives (for example anticoagulants), has been chosen as representative of other specimen types identified in the labelling, this should be described and supported
If the preparation of the specimen has not followed the protocol described in the current labelling, this should be identified and validated
A justification of the selection of the studies performed
Provide summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device.

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.

3.05.02.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.02.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.02.01.01 Summary

Folder name: 3.05.02.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.02.01.02 Full report

Folder name: 3.05.02.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.03 Metrological traceability of calibrator and control material values

Folder name: 3.05.03-MetrologicalTraceability

IMDRF common content

Evidence that supports the metrological traceability of values assigned to calibrators and trueness control materials. This should include:

A description of all calibrators and trueness control materials associated with the system
A justification of the selection of the studies performed
A summary of the evidence that falls within this category, including for example, methods and acceptance criteria for the metrological traceability to reference materials and/or reference measurement procedures and a description of value assignment and validation
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Notes:

Precision control materials used during analytical studies to establish the reproducibility of a measurement procedure do not require the assessment of metrological traceability to a reference material or a reference method.
The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the analytical performance study results provided in this section regarding the subject IVD medical device

Classification

New licence applications: Required

3.05.03.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.03.01-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.

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, 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 storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.03.01.01 Summary

Folder name: 3.05.03.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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 and amendment applications: Conditionally required – A comprehensive summary is required for each study/test presented in this section. The test summary should be sufficiently detailed to stand alone in describing the evidence

3.05.03.01.02 Full report

Folder name: 3.05.03.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.04 Accuracy of measurement

Folder name: 3.05.04-Accuracy

IMDRF common content

No content at this level.

Note: The general term measurement accuracy is currently used to cover both trueness and precision, whereas this term was used in the past to cover only the one component now named trueness. While measurement trueness, affected by systematic error, is normally expressed in terms of bias, measurement precision, affected by random error, is naturally expressed in terms of standard deviation. Accuracy is affected by a combination of systematic and random effects that contribute as individual components of the total error of measurement.

Classification

New licence applications: Required

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

3.05.04.01 Trueness

Folder name: 3.05.04.01-Trueness

IMDRF common content

This section should provide a summary of information and evidence relating to the trueness of the measurement procedure. Trueness measures apply to both quantitative and qualitative assays only when a reference standard or method is available. This should include:

A rationale for the reference standard or method(s) used
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the analytical performance study results provided in this section regarding the subject IVD medical device

Classification

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

3.05.04.01.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.04.01.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.04.01.01.01 Summary

Folder name: 3.05.04.01.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.04.01.01.02 Full report

Folder name: 3.05.04.01.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.04.02 Precision (Repeatability and Reproducibility)

Folder name: 3.05.04.02-Precision

IMDRF common content

A summary of evidence that supports the precision characteristics of the measurement of the subject IVD medical device is to be included in this section. This should include:

A justification of the selection of the studies performed.
A summary of the evidence that falls within this category, including:
1. Repeatability estimates and a brief summary about the studies used to estimate, as appropriate, within-run variability
2. Reproducibility estimates and a brief summary of the studies used to estimate, as appropriate, variability between days, runs, sites, lots, operators (intended users) and instruments. Such variability is also known as "Intermediate Precision"
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Notes:

Studies should include the use of specimens that represent the full range of expected analyte (measured) concentrations that can be measured by the product, as claimed by the manufacturer.
The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the analytical performance study results provided in this section regarding the subject IVD medical device.

Health Canada guidance

If a device is fully automated, site-to-site and operator-to-operator variability may not be relevant for reproducibility studies; justification should be provided.

Classification

New licence applications: Required

3.05.04.02.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.04.02.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.04.02.01.01 Summary

Folder name: 3.05.04.02.01.01-Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.04.02.01.02 Full report

Folder name: 3.05.04.02.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.05 Analytical sensitivity

Folder name: 3.05.05-AnalyticalSensitivity

IMDRF common content

Evidence that supports the analytical sensitivity of the subject IVD medical device is to be included in this section. This may include studies to establish the limit of blank (LoB), limit of detection (LoD), and/or limit of quantitation (LoQ). This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Health Canada guidance

Details regarding the study design should include, but are not limited to, the following.

The number of replicates tested at each concentration should be provided as well as a description of the method and calculation used to determine assay sensitivity. When applicable, the studies should include well-characterized, confirmed positive samples. Where applicable, samples representative of the different clades or strains of the pathogen detected should be used.

Ninety-five percent confidence intervals (CI) should also be provided.

Classification

New licence applications: Required

3.05.05.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.05.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.05.01.01 Summary

Folder name: 3.05.05.01.01-Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.05.01.02 Full report

Folder name: 3.05.05.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.06 Analytic specificity

Folder name: 3.05.06-AnalyticSpecificity

IMDRF common content

Evidence that supports the analytical specificity (interference, including as appropriate, selectivity, and cross reactivity) of the subject IVD medical device is to be included in this section. This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Health Canada guidance

Typically, studies supporting analytical specificity involve adding the potential interferent to the positive and negative samples and determining any difference relative to the control sample to which no interferent or cross-reacting substance/agent has been added. Interferents and cross reacting substances/agents, which vary greatly depending on the assay type and design, could derive from exogenous or endogenous sources such as:

substances used for patient treatment (for example therapeutic drugs, anticoagulants, etc.)
substances ingested by the patient (for example over the counter medications, alcohol, vitamins, biotin, foods, mouthwash, personal care products, etc.)
substances added during sample preparation (for example preservatives, stabilizers)
substances encountered in specific specimen types (for example haemoglobin, lipids, bilirubin, proteins)
analytes of similar structure (for example precursors, metabolites) or medical conditions unrelated to the test condition, including specimens negative for the assay but positive for a condition that may mimic the test condition (for example for a hepatitis A assay, test specimens negative for hepatitis A virus, but positive for hepatitis B virus)

Classification

New licence applications: Required

3.05.06.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.06.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.06.01.01 Summary

Folder name: 3.05.06.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.06.01.02 Full report

Folder name: 3.05.06.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.07 High dose hook effect

Folder name: 3.05.07-HighDoseHookEffect

IMDRF common content

Evidence that supports the absence of a high dose hook effect or prozone effect. This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Health Canada guidance

High dose hook effect should be determined for each claimed analyte. In the description of the study design, specify the method used to determine the analyte concentration and include a rationale for the highest dose evaluated.

Classification

New licence applications: Conditionally required – When any testing/study is conducted in support of the submission under the parent heading subject, this is required for each study/test.

3.05.07.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.07.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.07.01.01 Summary

Folder name: 3.05.07.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.07.01.02 Full report

Folder name: 3.05.07.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.08 Measuring range of the assay

Folder name: 3.05.08-MeasuringRange

IMDRF common content

Evidence that supports the measuring range (linear and non-linear measuring systems). This measuring range should include the lower limit of quantification. This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Health Canada guidance

Details regarding the study design should include, but are not limited to, the following.

Details regarding the study design should include a description of the analyte (measurand) levels and how the levels were established, as well as a description of the specimen type and matrix and how the samples were prepared for use in the study. The number of samples and the number of replicates at each concentration should be provided. Ninety-five percent confidence intervals (CI) should be provided.

Classification

New licence applications: Required

3.05.08.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.08.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.08.01.01 Summary

Folder name: 3.05.08.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.08.01.02 Full report

Folder name: 3.05.08.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.09 Validation of assay cut-off

Folder name: 3.05.09-ValofAssayCut-off

IMDRF common content

Evidence that supports the determining assay cut-off is to be included here. This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Health Canada guidance

This section should provide a summary of analytical data with a description of the study design including methods for determining the assay cut-off, including:

the population(s) studied (demographics/selection/inclusion and exclusion criteria/number of individuals included)
method or mode of characterization of specimens
statistical methods for example, Receiver Operator Characteristic (ROC) to generate results and if applicable, define grey-zone/equivocal zone

Classification

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.

3.05.09.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.09.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.09.01.01 Summary

Folder name: 3.05.09.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.09.01.02 Full report

Folder name: 3.05.09.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.05.10 Validation of the assay procedure

Folder name: 3.05.10-ValoftheAssayProcedure

IMDRF common content

This section should provide a summary of information and evidence supporting the validity of the assay procedure in terms of important reaction conditions (for example reaction time, reaction temperature, reagent volume, reading time). This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of study is not applicable to this case

Classification

New licence applications: required

3.05.10.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.05.10.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.05.10.01.01 Summary

Folder name: 3.05.10.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.05.10.01.02 Full report

Folder name: 3.05.10.01.02-Report

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06 Other studies

Folder name: 3.06-Other

IMDRF common content

No content at this level.

Classification

New and amendment applications: Conditionally required – When information does not belong in any of the other headings of this Chapter

3.06.01 Electrical systems: safety, mechanical and environmental protection, and electromagnetic compatibility

Folder name: 3.06.01-ElectricalSystems

IMDRF common content

Evidence supporting electrical safety, mechanical and environmental protection, and electromagnetic compatibility are to be included in this section. This should include:

A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of laboratory study is not applicable to this case

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device

Health Canada guidance

Electrical safety, mechanical and environmental protection, and electromagnetic compatibility may be demonstrated by compliance to an international or national standard. Where a recognized standard exists, a Declaration of Conformity to the recognized standard may be provided. IEC 61010-1 and -2 standards are frequently used for electrical safety and IEC 61326-1 and -2 for electromagnetic compatibility.

Classification

3.06.01.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.01.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.01.01.01 Summary

Folder name: 3.06.01.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.01.01.02 Full report

Folder name: 3.06.01.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06.02 Software/firmware/programmed or programmable medical

Folder name: 3.06.02-Software-Firmware

IMDRF common content

No content at this level. This section and associated sub-sections should include studies and supporting information on the software design, development process and evidence of the validation of the software, as used in the finished IVD medical device. It should also address all the different hardware configurations and, where applicable, operating systems identified in the labelling. Documentation should be organized according to software or hardware systems.

Classification

New and amendment applications: Conditionally required – Not required when this type of evidence/testing is clearly not applicable to the device or submission.

3.06.02.01 Software/firmware description

Folder name: 3.06.02.01-Description

IMDRF common content

The software description should include:

A comprehensive overview of significant software features and functions, which may include images, flow charts, and state diagrams as needed to adequately explain the software functionality
The version of the software. The version tested must be clearly identified and should match the release version of the software, otherwise justification must be provided
Identification of the IVD medical device features that are controlled by the software, the programming language, hardware platform, operating system (if applicable), use of off-the-shelf software (if applicable), a description of the realization process

If the product is a machine learning-enabled medical device (such as adaptive models, natural language processing, neural networks, and related approaches), please provide, as applicable:

a detailed description of each algorithm/model, including its inputs, outputs, data selection and management for training, testing, and validation (terminology may differ in different regions)
model selection and evaluation
risk management activities
materials/approaches used to provide transparency;
post-market performance monitoring activities

Health Canada guidance

All performance studies should be conducted with the software version as used in the finished device. Otherwise, rationale demonstrating that the software version tested does not impact the outcomes of the validation studies must be provided. The software version used in validation studies should be clearly identified.

If the software or a previous version of the software has been reviewed by Health Canada, this should be clearly stated and appropriate references provided (for example application and/or licence number).

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.02 Risk management file (including hazard analysis)

Folder name: 3.06.02.02-HazardAnalysis

IMDRF common content

The risk management file should be provided and include the risk management plan, risk assessment (for example hazard analysis), and risk management report.

The risk assessment (for example hazard analysis) should take into account all device hazards associated with the IVD medical device's intended use.

For Software that is part of a system, a risk assessment should be performed on the system comprising the software and its whole hardware environment and noted in the software documentation with reference to the particular section of the premarket submission.

IMDRF Health Canada content

The risk management file in this section should specifically relate to the software/hardware. Overall risk analysis should be placed in section 2.08.

For the risk control measures in the risk assessment or hazard analysis, there should be verification of the implementation of the risk control measures and verification of the effectiveness of the implemented risk control measures (that is, the implemented risk control measure reduces risk). This can be accomplished by tracing the identified hazard to the verified specific risk control measures (for example a requirement ID in the SRS and SDS, a test name and identifier in the testing documentation that shows pass/fail results, a user manual name and identifier, a training manual name and identifier).

Classification

New licence applications: Conditionally required – When software is part of the device

Amendment licence applications: Conditionally required – When relevant to the amendment

3.06.02.03 Software requirement specification (SRS)

Folder name: 3.06.02.03-SRS

IMDRF common content

The Software Requirements Specifications (SRS) documentation should describe the needs or expectations for a system or software, presented in an organized format, at the software system level or subsystem level, as appropriate, and with sufficient information to understand the traceability of the information with respect to the other software documentation elements (for example risk management file, software design specification, system and software architecture design chart, software testing).

The SRS documents the requirements for the software which typically specifies inputs and outputs, functions that the software will perform, hardware, performance, interfaces, user interaction, error definition and handling, intended operating environment, safety and security related requirements derived from a risk assessment (hazard analysis) and all ranges, limits, defaults, and specific values that the software will accept.

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.04 System and software architecture design (SAD) chart

Folder name: 3.06.02.04-SADChart

IMDRF common content

The System and Software Architecture Design (SAD) Chart should consist of detailed diagrams of the modules, layers, and interfaces that comprise the device, their relationships, the data inputs/outputs and flow of data, and how users or external products (including information technology (IT) infrastructure and peripherals) interact with the system and software. If the System and Software Architecture Design Chart is included in another document, such as the SRS, a reference to the location of the System and Software Architecture Design Chart in the submission should be included.

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.05 Software design specification (SDS)

Folder name: 3.06.02.05-SDS

IMDRF common content

Software Design Specification (SDS) documentation should be provided, including sufficient information to understand the technical design details of how the software functions, how the software design completely and correctly implements all the requirements of the SRS, and how the software design traces to the SRS in terms of intended use, functionality, safety, and effectiveness.

In terms of the relationship between the SRS and the SDS, the SRS describes what the software function will do and the SDS describes how the requirements in the SRS are implemented. The information presented in the SDS should be sufficient to ensure that the work performed by the software engineers who created the device software function was clear and unambiguous, with minimal ad hoc design decisions.

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.06 Traceability analysis

Folder name: 3.06.02.06-TraceabilityAnalysis

IMDRF common content

A Traceability Analysis links together your product design requirements, design specifications, and testing requirements. It also provides a means of tying together identified hazards with the implementation and testing of the mitigations.

IMDRF Health Canada content

The Traceability Analysis can be incorporated into the SRS documentation.

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.07 Software life cycle process description / software development, configuration management, and maintenance practices

Folder name: 3.06.02.07-SoftwLifeCycleProcessDesc

IMDRF common content

The Software Life Cycle Process Description / Software Development, Configuration Management, and Maintenance Practices description should describe the software development life cycle and the processes that are in place to manage the various life cycle activities.

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.08 Software testing as part of verification and validation

Folder name: 3.06.02.08-SoftwareV-V

IMDRF common content

Provide an overall description of the verification and validation activities performed for the final software version. You should provide the applicable test protocols and reports including the expected results, observed results and pass/fail determination.

Note: Discussion should address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.

Health Canada guidance

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 1–2 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

Amendment licence applications: Conditionally required – Not required when this type of evidence/testing is clearly not applicable to the amendment. If scientific judgement is required to justify why no information is required, then the heading is considered required and the justification should be provided.

3.06.02.08.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.02.08.01-StudyTitle,Identifier,Date(yyyy-mm-dd)

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.02.08.01.01 Summary

Folder name: 3.06.02.08.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.02.08.01.02 Full report

Folder name: 3.06.02.08.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06.02.09 Software version / revision level history

Folder name: 3.06.02.09-RevisionLevelHistory

IMDRF common content

The software version / revision level history documentation should include the history of software versions that were tested and documented as part of verification and validation activities. This typically takes the form of a line-item tabulation including the date, version number that was tested and a brief description of all changes in the version relative to the previously tested version.

The last entry in a line-item tabulation should be the final version to be incorporated in the released device. This entry should also include any differences between the tested version of software and the released version.

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.10 Unresolved software anomalies

Folder name: 3.06.02.10-UnresolvedAnomalies

IMDRF common content

Documentation should include a list of unresolved anomalies present in the software with the following items (for example in tabular format) for each unresolved anomaly:

A description of what the anomaly is and what root cause(s) of the anomaly could be
Identification of how the anomaly was discovered and, where possible, identification of the root cause(s) of the anomaly
Evaluation of the impact of the anomaly on the device's safety and effectiveness, including operator usage and human factors considerations;
Outcome of the evaluation; and
Risk-based rationale for not correcting or fixing the anomaly in alignment with the risk management plan or procedure(s)

Classification

New licence applications: Conditionally required – When software is part of the device.

Amendment licence applications: Conditionally required – When relevant to the amendment

3.06.02.11 Cybersecurity

Folder name: 3.06.02.11-Cybersecurity

IMDRF common content

For a description of the Cybersecurity Common Content, please refer to IMDRF/CYBER WG/N60 FINAL:2020 "Principles and Practices for Medical Device Cybersecurity"

IMDRF Health Canada content

Please consult the Pre-market requirements for medical device cybersecurity.

Health Canada guidance

Cybersecurity considerations should be included when a medical device contains or consists of software. If cybersecurity considerations are not addressed, provide evidence to support this decision.

This should include, but is not limited to, the following:

Cybersecurity vulnerabilities and risk analysis
Cybersecurity control measures
Traceability matrix linking cybersecurity controls to identified vulnerabilities and risks

This documentation ensures that all relevant cybersecurity risks have been properly assessed and managed throughout the development lifecycle.

Classification

New licence applications: Conditionally required – When the results of a risk assessment suggest that there are safety and effectiveness concerns relating to cybersecurity of the device, this is required.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.02.12 Interoperability

Folder name: 3.06.02.12-Interoperability

IMDRF common content

If the IVD medical device can communicate with other devices. Evidence to support the interoperability should be provided.

Classification

New licence applications: Conditionally required – When the results of a risk assessment suggest that there are safety and effectiveness concerns relating to the interoperability of the device, this is required.

Amendment licence applications: Conditionally required – When relevant to the amendment.

3.06.03 Cleaning and disinfection validation

Folder name: 3.06.03-Clean-DisinfectVal

IMDRF common content

Contains information on the validation of cleaning and disinfection instructions for reusable devices, including evidence to support maintenance of performance when subject to this procedure over a number of cycles that is representative of the IVD medical device's expected useful life. Information to be included in this section includes:

If applicable, a discussion of how the number of cycles that is representative of the IVD medical device's expected useful life has been determined
A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of laboratory study is not applicable to this case

Notes:

This applies most typically to devices intended for Point of care and/or home use (near patient testing) involving whole blood.
The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device.

Health Canada guidance

Demonstration of disinfection effectiveness can be made through viral challenge of material used to fabricate the device or by using a disinfection product with a Canadian Drug Identification Number (DIN) that has included evidence of inactivation of HBV in the Canadian DIN product monograph. In the latter case, the disinfection instructions provided in the device labelling must align with those in the product monograph.

Classification

3.06.03.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.03.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.03.01.01 Summary

Folder name: 3.06.03.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.03.01.02 Full report

Folder name: 3.06.03.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06.04 Usability/human factors

Folder name: 3.06.04–Usability-HumanFactors

IMDRF common content

Studies specifically assessing the instructions and/or IVD medical device design in terms of impact of human behavior, abilities, limitations, and other characteristics on the ability of the IVD medical device to perform as intended should be included here. This should include:

State the test environment and relation to the intended use environment
A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and conclusion to support why the evidence presented is sufficient to support the application

A statement of why this category of laboratory study is not applicable to this case

Notes:

If a clinical study has been conducted that includes usability/human factors endpoints, reference to the studies and endpoints should be made, but full results do not need to be repeated and should be included in Chapter 4 – Clinical Evidence.
The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device.

Health Canada guidance

Near patient IVDDs include Point-of-Care (POC) and Home-Use (self-testing) devices. Applications involving near patient IVDDs require a consumer field evaluation, which is a summary of studies conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use. These studies evaluate the performance of the device when used by the intended users without assistance, following instructions provided in the labelling.

The studies should also include a summary of results obtained from a questionnaire completed by the representative subjects following their use of the device. The questionnaire should evaluate the robustness and ease of use of the device, including an assessment of legibility and clarity of the Instructions for Use or Package Insert. For devices intended to be used for near-patient testing, a results interpretation study may be required, evaluating the ability of intended users to interpret all possible results using mock devices.

Classification

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

3.06.04.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.04.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.04.01.01 Summary

Folder name: 3.06.04.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.04.01.02 Full report

Folder name: 3.06.04.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06.05 Stability of the IVD

Folder name: 3.06.05–Stability

IMDRF common content

No content at this level

Classification

New licence applications: Required

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

3.06.05.01 Claimed shelf-life

Folder name: 3.06.05.01-ClaimedShelf-life

IMDRF common content

Contains details and evidence supporting the claimed shelf-life of the IVD medical device components (for example reagents, calibrators/reference materials, control material, any other components susceptible to degradation). Information provided in this section should include:

A description of recommended environmental conditions for storage of the IVD medical IVD medical device (for example temperature, pressure, humidity, light conditions)
A statement of the claimed shelf-life indicated as a period of time or any other means of appropriate quantification
An indication of the packaging used in any studies conducted in support of the shelf-life. If the packaging used in the studies differs from the final device packaging, a discussion of why the evidence can be consider valid in support of the claimed shelf-life
A description of the simulated transport conditions that the IVD was exposed to before the start of shelf-life studies
A justification of the selection of the studies performed
A summary of the evidence that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the claimed shelf-life.

A rationale that, for an indefinite period, the storage conditions could not affect IVD medical device safety or performance

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject device.

IMDRF Health Canada content

For devices that do not have an expiration period (for example electromedical equipment or other devices of multiple use), information regarding the estimated mean "lifetime". This mean "lifetime" can be indicated as number of procedures to be performed with the device and/or its accessories, as a period of time or any other means of appropriate.

For shelf-life testing of IVDs, both a stability protocol and a stability report must be included. The protocol must contain at a minimum a protocol number, revision number and date, claimed and tested use and storage conditions, observation time points, replicate number, time of baseline observations relative to stress conditions, a description of the data analysis, acceptance criteria to be met, and a description of the testing panel.

Health Canada guidance

Stability studies are required to demonstrate that the characteristics and performance of the IVDD shall not deteriorate under normal use to such a degree that the health or safety of a patient, user, or other person is adversely affected. For shelf-life, testing should be performed on at least three different lots manufactured under conditions that are essentially equivalent to routine production conditions (these lots do not need to be consecutive lots). If the device has multiple components, calibrators, and/or controls that are stored separately, the shelf life studies are required for each of the components.

Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claim but need to be followed up with real time stability studies. A minimum of 6 months real time data is required at the time of the licence application.

It is suggested that a Stability Evaluation Synopsis Table be provided with a summary of the shelf-life, in-use and shipping studies.

For amendment applications involving a modification to a licensed IVDD, if the stability claim(s) are unchanged, this should be stated. If the stability claim(s) are modified, an explanation should be provided along with supporting data. The explanation should include the original stability claims and the rationale for the change(s).

If an amendment application is for a shelf-life extension, the stability protocol(s) must be provided and clearly identified as being changed or unchanged from the original protocol. If a modification or deviation from the stability protocol occurred, a clear explanation is required.

Classification

New licence applications: Required

3.06.05.01.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.05.01.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.05.01.01.01 Summary

Folder name: 3.06.05.01.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.05.01.01.02 Full report

Folder name: 3.06.05.01.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06.05.02 In use stability

Folder name: 3.06.05.02-InUseStab

IMDRF common content

Contains details and evidence supporting the stability during actual routine use of the IVD medical device (real or simulated), including all applicable components (for example reagents, reaction cartridges). This may include open vial stability and/or, for automated instruments, onboard stability. Information provided in this section should include:

A description of recommended environmental conditions for use of the IVD medical device (for example temperature, pressure, humidity, light conditions)
A justification of the selection of the studies performed
A summary of the evidence, covering shelf-life period when stored at the proposed storage condition, that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A rationale that, for an indefinite period, the storage conditions could not affect IVD medical device safety or performance

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device.

IMDRF Health Canada content

Health Canada guidance

This section should provide information on in use stability studies for one lot reflecting actual routine use of the device (real or simulated). This may include open vial stability and/or, for automated instruments, on board stability and/or calibration stability.

Classification

3.06.05.02.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.05.02.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.05.02.01.01 Summary

Folder name: 3.06.05.02.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.05.02.01.02 Full report

Folder name: 3.06.05.02.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.06.05.03 Shipping stability

Folder name: 3.06.05.03-ShippingStab

IMDRF common content

Contains details and evidence supporting the tolerance of IVD medical device, or if provided separately, the components (for example reagents, calibrators/reference materials) to the specified or expected shipping conditions. Information provided in this section should include:

An indication of environmental conditions for correct shipment of the IVD medical device (temperature, pressure, humidity, light conditions, mechanical protection etc.)
A justification of the selection of the studies performed
A summary of the evidence, covering shelf-life period, that falls within this category
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A rationale that, for an indefinite period, the storage conditions could not affect IVD medical device safety or performance

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device.

IMDRF Health Canada content

Shipping stability should contain details and evidence supporting the tolerance of device components to the anticipated shipping conditions.

Health Canada guidance

Testing should be performed on at least one lot and may be performed under real and/or simulated conditions. Evidence that the IVDD is stable under variable shipping temperatures, i.e., freezing temperature (-20°C) and extreme heat defined as greater or equal to 37˚C, should be provided.

Alternatively, evidence that the IVDD is not exposed to temperature(s) outside the recommended storage range during shipping may be submitted. This can be achieved by providing evidence that the packaging is able to maintain the device at the recommended storage temperature when exposed to variable temperature, i.e., freezing temperature (-20°C) and extreme heat defined as greater or equal to 37˚C.

Classification

New licence applications: Required

3.06.05.03.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.06.05.03.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.06.05.03.01.01 Summary

Folder name: 3.06.05.03.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.06.05.03.01.02 Full report

Folder name: 3.06.05.03.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

3.07 Analytical performance and other evidence bibliography

Folder name: 3.07-AnalyticalPerformanceandOtherEvidenceBibliography

IMDRF common content

A listing of published studies relevant to the context of this chapter that involve this specific IVD medical device (for example analytical specificity, analytical sensitivity)
A legible copy of key articles, including translation where applicable to meet the regulators language requirements
A discussion and a conclusion to support why the evidence presented is sufficient to support the application

A statement that no literature related to the IVD medical device was found

Classification

New licence applications: Required

3.08 Other evidence

Folder name: 3.08-OtherEvidence

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. For example, for tests performed to ensure the safety and/or performance of the IVD medical device that are not delineated in the rest of the Chapter 3. In addition:

Describe the purpose of the test, the risk/safety issue the test is addressing; the test methods and results of the test
A justification of the selection of the studies performed.
A summary of the evidence that is being submitted under this heading
A discussion and a conclusion to support why the evidence presented is sufficient to support the application.

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the study results provided in this section regarding the subject IVD medical device.

Classification

New and amendment applications: Conditionally required – When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter

3.08.01 Study description, study identifier, date of initiation, date of completion

Folder name: 3.08.01-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.

Health Canada guidance

For example, when a storage and validation test are being included, the application would include two subfolders:

a custom folder named "3.5.01.01-Storage of serum samples (7 or 4 days), TR1525, 2017-10-28" containing two subfolders with the appropriate files:
- 1-Summ
  - TR1525Summ.pdf
- 2-Report
  - TR1525Report.pdf
a custom folder named "3.5.01.02-Validation of freeze/thaw cycles for serum samples, TR4584, 2017-11-29" containing:
- 1-Summ
  - TR4584Summ.pdf
- 2-Report
  - TR4584Report.pdf

Classification

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

3.08.01.01 Summary

Folder name: 3.08.01.01–Summ

IMDRF common content

A summary of the specific study described in the custom heading above.

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

3.08.01.02 Full report

Folder name: 3.08.01.02-Report

IMDRF common content

The test report for the test described in the custom heading above.

Health Canada guidance

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

Classification

New and amendment applications: Optional

Page details

2025-11-25

Class III IVD applications content and classification guidance: analytical performance and other evidence

On this page

Chapter 3: Analytical performance and other evidence

3.05 Analytical performance

3.05.01 Stability of specimen(s)

3.05.01.01 Study description, study identifier, date of initiation, date of completion

3.05.02 Validation of specimen

3.05.02.01 Study description, study identifier, date of initiation, date of completion

3.05.03 Metrological traceability of calibrator and control material values

3.05.03.01 Study description, study identifier, date of initiation, date of completion

3.05.04 Accuracy of measurement

3.05.04.01 Trueness

3.05.04.02 Precision (Repeatability and Reproducibility)

3.05.05 Analytical sensitivity

3.05.05.01 Study description, study identifier, date of initiation, date of completion

3.05.06 Analytic specificity

3.05.06.01 Study description, study identifier, date of initiation, date of completion

3.05.07 High dose hook effect

3.05.07.01 Study description, study identifier, date of initiation, date of completion

3.05.08 Measuring range of the assay

3.05.08.01 Study description, study identifier, date of initiation, date of completion

3.05.09 Validation of assay cut-off

3.05.09.01 Study description, study identifier, date of initiation, date of completion

3.05.10 Validation of the assay procedure

3.05.10.01 Study description, study identifier, date of initiation, date of completion

3.06 Other studies

3.06.01 Electrical systems: safety, mechanical and environmental protection, and electromagnetic compatibility

3.06.01.01 Study description, study identifier, date of initiation, date of completion

3.06.02 Software/firmware/programmed or programmable medical

3.06.02.01 Software/firmware description

3.06.02.02 Risk management file (including hazard analysis)

3.06.02.03 Software requirement specification (SRS)

3.06.02.04 System and software architecture design (SAD) chart

3.06.02.05 Software design specification (SDS)

3.06.02.06 Traceability analysis

3.06.02.07 Software life cycle process description / software development, configuration management, and maintenance practices

3.06.02.08 Software testing as part of verification and validation

3.06.02.09 Software version / revision level history

3.06.02.10 Unresolved software anomalies

3.06.02.11 Cybersecurity

3.06.02.12 Interoperability

3.06.03 Cleaning and disinfection validation

3.06.03.01 Study description, study identifier, date of initiation, date of completion

3.06.04 Usability/human factors

3.06.04.01 Study description, study identifier, date of initiation, date of completion

3.06.05 Stability of the IVD

3.06.05.01 Claimed shelf-life

3.06.05.02 In use stability

3.06.05.03 Shipping stability

3.07 Analytical performance and other evidence bibliography

3.08 Other evidence

3.08.01 Study description, study identifier, date of initiation, date of completion

3.08.01.01 Summary

3.08.01.02 Full report

Page details