Medical device real-world data and evidence in Canada: An environmental scan highlights



Key findings of environmental scan

Regulatory Leadership and Support

Stakeholder Engagement and Partnerships

Patient Engagement

Data Collection, Quality, and Analysis

Applications of RWE

Figure 1: Key Findings Derived from Environmental Scan on RWD and RWE for Medical Devices in Canada

Long Description
  • Online Survey
  • Literature Review
  • Key Informant Interviews

RWD and RWE for Medical Devices in Canada

Regulatory Leadership and Support

  • Guidance on submissions for therapeutic devices and IVDDs, such as reason for and appropriate RWE use
  • More systematic process for PMS
  • Develop and operationalize RWE generation and use with HTA organizations
  • Improve data access across Canada
  • Establish national registry for medical device implants

Stakeholder Engagement and Partnerships

  • Develop rationale and identify scenarios for appropriate use of RWE
  • Improve data collection and facilitate data sharing
  • Education and outreach on regulatory process
  • Federal and provincial partnerships required
  • Collaborations with RWE experts
  • Form a governance

Patient Engagement

  • Involve patients in the RWD and RWE process
  • Option to opt out at any time
  • Support RWE use for decisions
  • Most willing to share anonymized or de-identified medical data to not-for-profit entities
  • Knowledge translation can increase clarity of RWD and RWE terms

Data Collection, Quality, and Analysis

  • Consistency in data collection required
  • Agreed upon minimal registry data sets
  • Data quality measurement and context of data collection can increase RWE uptake
  • Robust scientific methods for RWD are critical
  • Funding required for data collection and maintenance

Applications of RWE

  • Support in RWE use for regulatory decisions and HTA recommendations
  • Other possible applications include: assessment of care providers, understand patient care pathways, health resource use, measurement of safety and effectiveness, and procurement decisions

HTA=Health technology assessment; IVDDs=In-vitro diagnostic devices; PMS=Post-market surveillance; RWD=Real-world data; RWE=Real-world evidence

Next steps


Footnote 1

Center for Devices and Radiological Health, Food and Drugs Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 2017; Accessed January 4, 2019

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Footnote 2

Members of the Pan-Canadian Health Technology Assessment Collaborative comprise of Health Quality Ontario, l’Institut national d'excellence en santé et services sociaux, the Institute of Health Economics, the British Columbia Health Technology Assessment Office, and Canadian Agency for Drugs and Technologies in Health.

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Footnote 3

Health Canada and Pan-Canada Health Technology Assessment Collaborative. A Strategy to Optimize the Use of Real-World Evidence across the Medical Device Life Cycle in Canada. 2019.

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