Guidance on clinical evidence requirements for medical devices: Overview
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This document provides guidance to manufacturers of Class III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices. Guidance is provided on:
- when clinical data/evidence is required
- the common methods to generate clinical data
- how to compare devices appropriately
Specifically, this guidance document outlines:
- when clinical data/evidence may be required as part of a pre-market licence application
- the types and quality of clinical evidence that may be required to support the safety and effectiveness of a medical device
- the use of clinical evidence from comparator devices for the purpose of a pre-market application
- the various ways that clinical data may be generated
- the various ways sex, gender and other factors may be integrated
- when clinical data/evidence may be required as part of a post-market obligation
The Medical Devices Regulations (Regulations) use a risk-based approach to regulating products within their scope. The safety and effectiveness evidence requirements are identified in sections 10 to 20.
The evidence required to support a medical device licence application is proportional to the risk of the device. This is determined by applying the classification rules for medical devices detailed in Schedule 1 of the Regulations. Medical devices are categorized into 4 classes based on the risk associated with their use. Class I devices present the lowest potential risk (for example, a tongue depressor) and Class IV devices present the greatest potential risk (for example, a pacemaker).
To demonstrate the safety and effectiveness of a Class III or IV medical device, manufacturers should submit the required, applicable information outlined in this guidance. Manufacturers should also consult this guidance when clinical evidence is requested for Class II devices.
Scope and application
This guidance should be read along with the following guidance documents:
- Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs)
- Draft Health Canada IMDRF table of contents for medical device applications
This guidance expands upon:
- section 5.3 (clinical evidence) of the Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including in vitro diagnostic devices (IVDDs)
- section 4 (clinical evidence) of the Class 3, non-in vitro diagnostic devices (nIVD), new and amendment applications (part of the IMDRF table of contents for medical device applications mentioned above)
- section 4 (clinical evidence) of the Class 4, non-in vitro diagnostic devices (nIVD), new and amendment applications (part of the IMDRF table of contents for medical device applications mentioned above)
This guidance also outlines the general principles and criteria for clinical evidence that supports:
- Class III and IV medical device licence applications or
- other points over the lifecycle of a device
The clinical evidence described in this document should be submitted for review as part of either:
- the general data requirements listed in subsections 32(3) and (4) of the Regulations or
- a request for post-market evidence as per section 39
This guidance does not apply to in vitro diagnostic devices (IVDDs).
Manufacturers should also consult other relevant guidance documents as appropriate, including for their device type. For a list of related guidance, see the Related links section below.
Please also read the companion document Clinical Evidence Requirements for Medical Devices: Examples. It contains examples of when clinical evidence is more likely or less likely to be required for different types of devices.
In line with international standards, this guidance document adopts many terms defined in the following references:
- Clinical evidence - Key definitions and concepts (International Medical Devices Regulators Forum)
- Clinical investigation of medical devices for human subjects - Good clinical practice (International Organization for Standardization)
Clinical data: Safety, clinical performance and/or effectiveness information that is generated from the clinical use of a medical device.
Clinical evidence: Clinical data and its evaluation pertaining to a medical device.
Clinical evaluation: Assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of a medical device when used as intended by the manufacturer.
Clinical investigation: A systematic investigation (or clinical study) in human subjects undertaken to assess the safety and/or effectiveness of a medical device.
Clinical investigation plan: Document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of a clinical investigation.
Comparator device: Any medical device with one or more characteristics as the subject device. If the comparator device is being used to supplement or replace clinical evidence for the subject device, then similar design, technology and usually intended use and/or indications for use will be required.
A comparator device should be licensed in Canada. If not, please provide objective evidence of safety and effectiveness to Health Canada, along with a side-by-side comparison of device specifications.
Established technology: A technology that is well understood through recognized standards, pre-clinical data, extensive literature, real-world data and clinical data, and has an established risk/benefit/uncertainty profile.
Indications for use: A general description of the disease or condition the medical device or IVD medical device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the medical device or IVD medical device is intended.
Intended use/intended purpose: The objective intent regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer. (Note: The intended use can include the indications for use.)
Manufacturer: A person who:
- sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person and
- is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf
Real World Data (RWD): Clinical data on patient status and/or the delivery of health care collected from a variety of sources (for example, data collected from data registries, electronic health records).
Real World Evidence (RWE): Clinical evidence on the usage and potential benefits or risks of a medical product derived from analysis of real-world data (for example, information derived from multiple RWD sources).
Sex and Gender-Based Analysis Plus (SGBA+): An analytical process used to assess how diverse groups of women, men, girls, boys and gender-diverse people may be impacted by products or federal initiatives by considering biological factors related to sex, socio-cultural factors related to gender and other identity factors. Federal initiatives include research, legislation, policies, regulations, programs and services.
Subject device: The medical device referred to in the medical device application.
Note about guidance documents in general
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied by hospitals. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We must make sure that such requests are justifiable and that decisions are clearly documented.
- Elements of real world data/evidence quality throughout the prescription drug product life cycle
- Applications for medical device investigational testing authorizations guidance document - Summary
International Medical Device Regulators Forum:
International Organization for Standardization:
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 11979-7: 2018 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
- ISO 11979-10: 2018 Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
- ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
- IEC 62366-1:2015 Medical Devices - Part 1: Application of usability engineering to medical devices
- IEC 60601-1-1:2010 Medical electric equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Association for the Advancement of Medical Instrumentation:
- World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects (World Health Organization)
- Sex and gender - Gender diversity (Women and Gender Equality Canada)
- Ethical conduct for research involving humans (Government of Canada)
- Clinical evaluation (Global Harmonization Task Force)
- Clinical evidence guidelines - Medical devices (Department of Health, Government of Australia)
- Guidelines on medical devices - Clinical evaluation: A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC (European Commission)
- Reporting of computational modeling studies in medical device submissions (U.S. Food and Drug Administration)
- Use of real-world evidence to support regulatory decision-making for medical devices (U.S. FDA)
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