The Use of Real-World Evidence for Medical Device Assessment: An Environmental Scan


Project Line:
Health Technology Review
Project Number:

Health Canada and the Pan-Canadian Health Technology Assessment Collaborative have developed a strategy for optimizing the use of real-world evidence (RWE) to improve the accessibility, affordability, and appropriate use of medical devices across the product life cycle. To inform the development of an RWE framework, CADTH undertook an Environmental Scan to determine how RWE is being used in Canada by both regulators and health technology assessment (HTA) producers.

The key objectives of this Environmental Scan were to:

  • describe the eligibility criteria for the inclusion of RWE to establish device effectiveness and safety for assessments done by Health Canada and HTA organizations
  • describe how organizations use the RWE of effectiveness and safety in assessments conducted to support regulatory decisions or HTA recommendations
  • describe the perceived impact of RWE on assessments.


The Use of Real-World Evidence for Medical Device Assessment ─ An Environmental Scan

Environmental Scan
PUBLISHED: March 2020