Clinical Evidence Requirements for Medical Devices – Health Canada Guidance

Purpose and Regulatory Context

This guidance assists manufacturers in determining the type and amount of clinical evidence required to support medical device licence applications for Class II, III, and IV devices under the Medical Devices Regulations. Clinical evidence is essential to demonstrate that a device is safe and effective for its intended use. The level of evidence required is risk-based, proportional to device classification, novelty, and potential patient impact. Source: Clinical Evidence Requirements for Medical Devices - Canada.ca

Risk-Based Approach to Clinical Evidence

Health Canada adopts a risk-based framework where evidence requirements increase with device risk class and novelty:

• Class II: Generally lower evidence threshold; literature, bench testing, or limited clinical data often sufficient
• Class III & IV: Higher evidence threshold; usually require clinical investigations or robust existing clinical data
• Novel devices or those with high-risk intended uses (e.g., life-supporting, implantable) require stronger prospective clinical evidence

Types of Clinical Evidence Accepted

Multiple forms of evidence may be combined to build a comprehensive safety and effectiveness profile:

Published Literature

• Peer-reviewed studies, systematic reviews, meta-analyses
• Acceptable when high-quality, relevant, and directly applicable to the device and intended use
• Limitations include potential publication bias and applicability to the specific device design

Non-Clinical Data

• Bench testing (mechanical, electrical, biocompatibility)
• Animal studies demonstrating performance in vivo
• Computer modeling/simulation for certain device types (e.g., software, implants)

Clinical Investigations

• Prospective studies (e.g., IDE-equivalent, pre-market clinical trials)
• Required for novel high-risk devices or when existing data are insufficient
• Should follow Good Clinical Practice (GCP) principles

Real-World Evidence

• Post-market data from registries, observational studies, or prior use in other jurisdictions
• Can supplement or, in some cases, substitute for pre-market clinical trials for well-established technologies

Considerations for Different Device Scenarios

• Well-established technologies: Reliance on published literature and historical data often sufficient
• Incremental changes to licensed devices: May require only targeted clinical data or bridging studies
• Novel or high-risk devices: Prospective clinical investigations usually required, with defined endpoints, sample size, and follow-up duration
• In vitro diagnostic devices: Clinical performance studies evaluating diagnostic accuracy, sensitivity, specificity

Documentation and Submission Expectations

• Provide a clinical evaluation report summarizing all evidence and justifying conclusions
• Include benefit-risk analysis integrating clinical, non-clinical, and risk management data
• Clearly identify gaps in evidence and mitigations for residual risks
• For Class III/IV devices, pre-submission consultation with Health Canada is recommended

This guidance promotes consistent, proportionate clinical evidence requirements while ensuring patient safety. Detailed examples, acceptable study designs, literature appraisal criteria, and submission templates are provided in the official Health Canada clinical evidence requirements guidance for medical devices. Source: Clinical Evidence Requirements for Medical Devices - Canada.ca