Class IV IVD applications content and classification guidance: Submission context

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.

On this page

• Chapter 2: Submission context
• 2.02 General summary of submission
• 2.04 Device description
• 2.05 Indications for use and/or intended use and contraindications
• 2.06 Global market history
• 2.07 Post-market study plans
• 2.08 Risk management
• 2.10 Standards
• 2.11 Other submission context information

Chapter 2: Submission context

Folder name: 2-CONTEXT

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

2.02 General summary of submission

Folder name: 2.02-GeneralSummaryofSubmission

IMDRF common content

1. Statement of the device type (for example Tacrolimus test system, blood specimen collection device, calibrator) and name (for example trade name, proprietary name), its general purpose, and a high-level summary of key supporting evidence (that is, studies that are unique to the risks of this device type).
2. Summary of submission, including:
   1. the type of submission (for example new, amendment, change of existing application, renewal)
   2. if amendment/supplement, the reason of the amendment/supplement
   3. if a change to existing approval, description of the change requested (for example changes in design, performance, indications, changes to manufacturing processes, manufacturing facilities, suppliers)
   4. any high-level background information or unusual details that the manufacturer wishes to highlight in relation to the device, its history or relation to other approved devices or previous submissions (provides context to submission)

IMDRF Health Canada content

If amendment or new submission based on currently licenced device(s), the Canadian medical device licence number(s) should be provided along with the description of the change requested. 

If amendment, there may be multiple sections where there is “no change”. These folders would thus be considered “Not applicable”. A list of these sections may be provided here, identified as “no change” and then the appropriate folders would be excluded from the submission.

If amendment or new submission, if a report can fit into multiple sections, only one copy should be included and references to the single copy provided in other sections where the information might be applicable.

If requesting priority review per Section 15 of the application form, the justification should be provided here.

Health Canada guidance

For amendment submissions, the general summary should clearly identify which sections of the application are impacted by the proposed changes.

A brief risk-based justification should be included to explain why these specific sections are affected and why other sections remain unchanged.

Classification

New and amendment applications: Required

2.04 Device description

Folder name: 2.04-DeviceDescription

IMDRF common content

No content at this level.

Classification

New and amendment applications: Required

2.04.01 Comprehensive device description and principle of operation

Folder name: 2.04.01-ComprehensiveDeviceDesc-PrincipleofOp

IMDRF common content

1. A general description of the device, including:
   1. The device name
   2. What does it do?
   3. Who uses it and for what? (high level statement)
   4. Where to use it? (places/environment where the device is intended to be used)
   5. General description of the principle of the assay method or instrument principles of operation
   6. Description of the components (for example reagents, assay controls, calibrators, cassette, etc.) and where appropriate, a description of the reactive ingredients of relevant components (such as antibodies, antigens, nucleic acid primers, probes, etc.)
   7. If applicable, labelled pictorial representation (diagrams, photos, drawings)
   8. If system, how the components relate?
   9. If applicable, identify if the device incorporates software/firmware and its role
   10. If applicable, identify the instrument(s) required to perform the test
2. Product specification, including:
   1. Physical characteristics of relevance to the end user (dimensions, weight)
   2. If applicable, technical features and operating modes
   3. If applicable, operating specifications and performance characteristics (for example electrical power requirements, settings and associated allowable ranges/limits, units of measure, temperature and humidity limits, throughput (number of tests per hour), analytical and clinical sensitivity and specificity)
   4. If applicable, a complete list of the configurations/models of the devices and a summary of the differences in specifications (comparison table and/or pictures/diagrams with supporting text)
3. Describe the different specimen types that can be used for this device (for example serum, plasma, urine, cerebrospinal fluid), including any additives that are required (for example anticoagulant).
4. Describe the use of controls. If applicable, a list of compatible control materials or control material specifications.
5. Description of the accessories, other IVD or non-IVD medical devices and other products, which are intended to be used in combination with the IVD medical device.
6. If approved by the regulator, provide the approval number and identification for each of the accessories, other IVD or non-IVD medical devices and other products, which are intended to be used in combination with the IVD medical device.
7. If applicable, indication of biological material or derivate used in the medical device, including:
   1. origin (human, animal, recombinant or fermentation products or any other biological material)
   2. source (for example blood, bone, heart, any other tissue or cells)
   3. where a significant risk is identified, a brief summary of evaluations performed to minimize biological risks, in particular, with regard to viruses and other transmissible agents
8. Description of the collection and/or transport container(s) provided with the IVD medical device or a description of specifications or recommended collection and/or transport container(s).
9. If applicable, a listing of assays that are compatible with the instrument.
10. If applicable, a listing of compatible instruments.
11. A list of any software to be used with the IVD medical device and a description of its role in the delivery of the intended purpose.
12. If applicable, engineering diagrams/prints/schematics of the device (should be provided as a separate file within the submission).

Note: The sponsor/applicant should explicitly address any existing regional regulatory guidance related to the comprehensive device description and principles of operations provided in this section regarding the subject device.

IMDRF Health Canada content

If the application is an amendment, this section should describe the up-to-date device as applied for in the amendment, that is, including the modifications. Modifications (for example changes in design, performance and indications) should be further detailed in Section 2.04.04 below. Components or accessories that can be sold separately should be identified.

Health Canada guidance

With respect to (g), a list of biological materials is not normally required. Usually for an IVDD, risk associated with biological materials is mitigated in the labelling (for example warnings and precautions) as well as by using control material that has been shown to be free of potentially infectious material (i.e. either tested and shown to be negative or else subject to an acceptable inactivation procedure).

Classification

New and amendment applications: Required

2.04.02 Material specifications

Folder name: 2.04.02-MaterialSpecifications

IMDRF common content

Details of relevant material identifications and specifications, including critical raw materials and components should be provided. Information should include complete chemical and physical characterization of all component materials.

Note: If applicable, chemicals should be identified using either the IUPAC (International Union of Pure and Applied Chemistry) or the CAS (Chemical Abstract Service) Registry number. Reference to applicable material standards may also be useful in this description.

Classification

New licence applications: Required 

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

2.04.03 Description of device packaging

Folder name: 2.04.03-DescriptionofDevicePackaging

IMDRF common content

1. A brief description of the packaging of the devices, including the packaging configuration and materials involved. This is not intended to include shipping/transport packaging.
2. Specific packaging of accessories marketed together with the IVD medical devices shall also be described.

Classification

New licence applications: Required

Amendment licence applications: Conditionally required – Required if there have been changes in the packaging since the previous submission or if the packaging is relevant to the submission (for example, there has been a change in shelf life or sterilization methods)

2.04.04 History of development

Folder name: 2.04.04-HistoryofDevelopment

IMDRF common content

For any device versions/prototypes referenced in the evidence presented in the submission, a table describing the version/name, with 4 columns (Device Name and/or Version; Description of changes from previous row; motivation for the change; list of verification/validation activities, including clinical studies, conducted using this version).

For any design verification or validation activities presented in this submission (including clinical studies) performed on any earlier versions of the subject device, include a justification for why the changes do not impact the validity of the data collected under those activities in supporting the safety and performance of the final IVD medical device design.

IMDRF Health Canada content

It is highly recommended that a description of all changes made to the device since the issuance of the last medical device licence or licence amendment be provided for a device that has had a previous version licensed in Canada.

Health Canada guidance

For devices that currently hold a licence in Canada, include any changes (significant, manufacturing, or non-significant) that have occurred since the device was licensed or last amended and not just those limited to the subject of this application.

Classification

New licence applications: Required

Amendment licence applications: Required

2.04.05 Reference and comparison to similar and/or previous generations of the device

Folder name: 2.04.05-Ref-ComparisontoSimilarand-orPreviousGen

IMDRF common content

1. A list of the similar devices (available on local and international market) and/or previous generation of the devices (if existent) relevant to the submission. This should include any similar/previous generation devices that were previously reviewed and refused by the subject regulator
2. Description of why they were selected
3. A key specification comparison, preferably in a table, between the references (similar and/or previous generation) considered and the device

IMDRF Health Canada content

1. If the application is an amendment to a licenced device or is based on a modification of a licensed device, a description of the modifications is required (for example changes in design, performance, and indications).
2. Comparisons can be used to support the safety and effectiveness of the device if they are made to a currently licensed device in Canada. If this method is used, ensure the Canadian Medical Device Licence Number of the comparator is stated. Include a comparison of indications for use and the technology between the comparison device and the subject device. The comparison device does not need to be manufactured by the same manufacturer.

Health Canada guidance

If the licence or licence amendment involves an instrument that is part of a series, for example, Analyzer ABC, Analyzer ABC-light, Analyzer ABC-semi-automated, etc., a summary and a brief history of the instrument series should be provided. This is applicable for all situations, even if an instrument is licensed on a separate licence, if the previous model is discontinued, etc. Sufficient information should be provided to enable Health Canada to understand the relationship between the instrument and the other instruments in the series. The information should list the instruments in the series, indicating the variation(s) in names (if applicable), the catalog numbers, and the licence numbers. The differences and similarities between the instruments should be highlighted and/or provided in a table format.

This information should be provided with every application and amendment related to the instrument and also with every assay that is intended to be used with the instrument(s), if applicable. A tabular, flowchart, or schematic representation of the information is recommended.

When adding a device identifier, comparative information is necessary to validate compliance with licence type requirements. Include a comparison table that outlines all differences between the devices represented by the new identifiers and a closely related licensed comparator(s).

Classification

New licence applications: Required

Amendment licence applications: Conditionally required – If applicable to the amendment.

2.05 Indications for use and/or intended use

Folder name: 2.05-Indications-IntendedUse-Contraindications

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.

Classification

New and amendment applications: Required

2.05.01 Intended use, intended purpose, intended user, indications for use

Folder name: 2.05.01-IntendedUseandIndications

IMDRF common content

This section should include, as appropriate:

1. Intended use: The statement of intended use should specify what specific disorder, condition, or risk factor of interest (that is, the analyte to be measured) is detected and the purpose provided by the device (for example screening, monitoring, diagnosis or aid to diagnosis). It should identify:
   1. instruments on which the device can be used
   2. if the assay is automated or not
   3. is the IVD medical device qualitative or quantitative
   4. and the specimen types (for example serum, plasma, urine, cerebrospinal fluid), including any additives that are required (for example anticoagulant)
2. Intended user: Lay person or professional?
3. Identify if the device is intended for single or multiple use
4. Indications for use:
   1. Disease or medical condition that the device will diagnose, treat, prevent, mitigate, or cure, parameters to be monitored and other considerations related to indication for use
   2. If applicable, information about patient selection criteria
   3. If applicable, when/where the use of the IVD medical device should be avoided
   4. If applicable, information about intended patient population (for example adults, pediatrics or newborn) or a statement that no subpopulations exist for the disease or condition for which the device is intended
5. For amendments/supplements or changes to existing approvals, identify any changes to the previously approved intended use/intended purpose/intended user/indications. If there are no changes, this should be stated, and a reference should be made to the precise regional regulatory tracking number associated with the previous submission/approval

Notes:

1. The statements of intended use and indications for use must be as presented in the labelling.
2. If more than one device is included, the information should be provided for each device.

IMDRF Health Canada content

The content of this section should be contained in a single body of text.

Health Canada guidance

The Guidance Document - Labelling of In Vitro Diagnostic Devices should be consulted for additional guidance.

Classification

New and amendment applications: Required

2.05.02 Intended environment, setting for use

Folder name: 2.05.02-IntendedEnvironment-Setting

IMDRF common content

1. The setting where the device is intended to be used (for example home use, domestic use, self-testing, near-patient, point of care). Multiple options can be indicated
2. If applicable, environmental conditions that can affect the device’s safety and/or performance (for example temperature, humidity, power, pressure, movement)

Health Canada guidance

The Medical Devices Regulations defines near-patient testing device as an in vitro diagnostic device that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional’s office or the bedside. This definition includes both point of care and self-testing. If a device is described as a near-patient testing device, it should be clarified if it is intended to be used for self-testing or home-use purposes or not.

Classification

New and amendment applications: Required

2.06 Global market history

Folder name: 2.06-GlobalMarketHistory

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.

Classification

New and amendment applications: Required

2.06.01 Global market history

Folder name: 2.06.01-GlobalMarketHistory

IMDRF common content

1. Up to date indication of the markets (all countries or jurisdictions) where the device is already marketed, including any marketing under compassionate use regulations
2. Should include history of the marketing of the device by any other entity in as much detail as possible, acknowledging that detailed information may not be available in all cases
3. Include a list of all countries in which the device has been removed from marketing for any reason related to the safety or effectiveness of the device

IMDRF Health Canada content

1. If the subject device is different in any way (for example design, labelling, specifications, indications) from those approved or marketed in other jurisdiction, the differences should be described.
2. The month and year of market approval in each country or jurisdiction where the device is marketed. If the device has been marketed for greater than 10 years, a statement of greater than 10 years can be made.
3. For each of the markets listed in (a) above, a statement of the commercial names used in those markets or a clear statement that the commercial names are the same in all jurisdictions
4. State the date of data capture for the market history data
5. If the subject device has been the subject of any previous compassionate use and/or clinical trials this should be identified and, if applicable, relevant reference numbers provided

If there is any approval number, given to the device by the regulator authority of the markets (country or jurisdictions) where the device is already marketed, this identification must be informed.

1. If applicable, market history should include data for previous generations of the device.
2. Information regarding any Canadian Investigational Testing Authorizations should be included.

In this context, compassionate use includes any Special Access Authorizations.

Health Canada guidance

If the device has not previously been licensed in Canada, this should be stated. The authorization reference numbers from the regulatory agencies (for example United States Food and Drug Administration (FDA) 510k or PMA number) should be included.

Classification

New and amendment applications: Required

2.06.02 Incident reports and recalls

Folder name: 2.06.02-IncidentReports-Recalls

IMDRF common content

1. List adverse events/incidents associated with the device and a statement of the period associated with this data
2. If the number of events is voluminous, provide a summary by event type that states the number of reported events for each event type
3. List of the IVD medical device recalls and/or advisory notice, and a discussion of the handling and solution given by the manufacturer in each case
4. A description of any analysis and/or corrective actions undertaken in response to items listed above
5. If there have been no adverse events/incidents, recalls and/or advisory notice to date, provide an attestation from device owner on company letterhead, that there have been no adverse events/incidents, recalls and/or advisory notice since commercial introduction of the device

Note: It is acknowledged that the definition of recall may vary from one jurisdiction to another.

Health Canada guidance

All incident reports and recalls in Canada including international market involving previous version(s) of the device, Special Access request(s), and Investigational Testing Authorization request(s) should also be summarized here.

Classification

New and amendment applications: Required

2.06.03 Sales, incident and recall rates

Folder name: 2.06.03-SalesIncident-RecallRates

IMDRF common content

1. A summary of the number of units sold in each country/region and a statement of the period associated with this data.
2. Provide the rates calculated as follows for each country/region:
   1. Incident rate = # adverse events/incidents divided by # units sold expressed as a percentage
   2. Recall rate = # recalls divided by # units sold expressed as a percentage
   Rates may be presented in other appropriate units such as per patient year of use or per use. In this case, methods for determining these rates should be presented and any assumptions supported.
3. Critical analyses of the rates calculated (for example, Why are they acceptable? How do they break down in terms of incidents? Is there some outlier data that has driven the rates up? Are there any trends associated with any sub-groups of the devices that are subject of the submission (for example, size, version)?).

Notes:

1. It is acknowledged that the definition of recall may vary from one jurisdiction to another.
2. Sales in this context should be reported as the number of units sold.

Health Canada guidance

For devices that have a long marketing history (more than 10 years), a summary of the number of units sold in each country/region (sales) for the most recent five years can be provided in lieu of a complete marketing data.

Classification

New and amendment applications: Required

2.07 Post-market study plans

Folder name: 2.07-Post-MarketStudyPlans

IMDRF common content

Post-market study plans may include clinical or nonclinical study plans. The documentation provided here will not include final reports and analysis, and instead includes study plan information only. This may include:

1. Study objectives
2. Study design
3. Subjects and sites information
4. Endpoints (primary and secondary)
5. Summary of data analysis plan
6. Length and frequency of follow-up

Note: Post-market non-clinical or clinical data from one region provided during the pre-market phase to a second region would be considered non-clinical or clinical data for the second region and would reside in Chapter 3 or Chapter 4, respectively.

Classification

New and amendment applications: Optional

2.08 Risk management

Folder name: 2.08-RiskManagement

IMDRF common content

1. A summary of the risks identified during the risk analysis process and how these risks have been controlled to an acceptable level. Plans can be considered part of the risk management documentation
2. The results of the risk analysis should provide a conclusion with evidence that remaining risks are acceptable when compared to the benefits
3. Where a standard is followed, identify the standard

Health Canada guidance

The risk assessment should be conducted on the version of the device(s) under review. If the application is an amendment or a modification of a previously licensed Class IV device, the risk assessment should focus on the new and/or modified risks and their mitigation. If the original risk assessment is updated, the new risks or modified risks should be clearly highlighted. It is recommended that the current version of ISO 14971-1, entitled Medical devices – Application of risk management to medical devices, be consulted.

Classification

New and amendment applications: Required  

2.10 Standards

Folder name: 2.10-Standards

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.

Classification

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

2.10.01 List of standards and guidance documents

Folder name: 2.10.01-ListofStandards

IMDRF common content

This section should include:

1. If applicable, a list of the standards that have been complied with in full or in part in the design and/or manufacture of the device
   1. At a minimum should include the standard organization, standard number, standard title, year/version, and if full or partial compliance
   2. If partial compliance, a list of the sections of the standard that:
      • are not applicable to the device, and/or
      • have been adapted, and/or
      • were deviated from for other reasons – discussion to accompany
2. If applicable, a list of relevant guidance documents published by regulators and referenced in the design and/or manufacture of the device with the jurisdiction of publication, publication date and title identified
3. If applicable, a list of relevant clinical guidelines referenced in the design and/or manufacture of the device, the publisher, publication date and title identified.

Health Canada guidance

The use of standards is not compulsory. The manufacturer may choose to demonstrate safety and effectiveness independent of any international or national standard.

Demonstrating conformity with Health Canada-recognized standards facilitates the premarket review process. Conformity with other more general standards, e.g., device-specific standards that may not encompass all aspects of device performance, can also streamline the premarket review process.

Health Canada’s guidance on using standards to support compliance with the Medical Devices Regulations may be consulted for assistance.

Classification

New licence applications: Conditionally required – If demonstrating that device complies with standards

Amendment licence applications: Conditionally required – If there are standards that have been applied in relation to the amendment

2.10.02 Declaration and/or certification of conformity

Folder name: 2.10.02-Declarationand-orCertificationofConformity

IMDRF Health Canada content

The applicant is advised to prepare the Declaration of Conformity form to recognized standards using Health Canada's Declaration of Conformity form. Refer to the guidance on using standards to support compliance with the Medical Devices Regulations and the current list of recognized standards for medical devices.

Health Canada guidance

If the standard is recognized by Health Canada and if the acceptance criteria specified in the standard can be met with pass or fail results, then in some cases it may not be necessary to review the test data for those aspects of the device addressed by the standard. For example, a Declaration of Conformity to a Health Canada recognized electrical or electromagnetic compatibility standard will usually eliminate the need to provide the test data. In most cases, however, a summary of the test data is required even though a Declaration of Conformity is provided, particularly when acceptance criteria are not specified in the standard. For example, if conformance is declared to CLSI EP5, Evaluation of precision of quantitative measurement procedures; approved guideline, acceptance criteria and a summary of the precision study results are required.

Classification

New licence applications: Conditionally required – If demonstrating that device complies with standards

Amendment licence applications: Conditionally required – Not required if clearly not applicable to the amendment

2.11 Other submission context information

Folder name: 2.11-OtherSubmissionContextInformation

IMDRF common content

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

Note: To ensure all elements of your submission are adequately reviewed, please be sure that any content placed here does not belong under any heading described above.

Classification

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