Strengthening the use of real world evidence and regulations for medical devices

From: Health Canada

This project aims to improve our ability to monitor medical device safety and effectiveness across the product life cycle. It will also help us to develop new regulatory options to prevent and mitigate safety risks.

This project will result in:

  • an improved ability to monitor the safety and effectiveness of medical devices throughout the product life cycle
  • a better understanding of the strategic use of real world evidence (RWE) from the pre-market development stage through to post-market surveillance and risk management
  • the availability of new regulatory options to identify and manage risks, such as additional powers to request information from manufacturers

We expect the outcomes of this project to include:

  • better use of RWE across the product life cycle for regulatory decision making
  • more attention on the post-market aspect of medical devices to improve regulatory oversight throughout the product life cycle
  • a more proactive surveillance model for monitoring the safety and effectiveness of medical devices throughout their life cycle
  • an enhanced ability to manage identified safety risks for medical devices

The tasks for this project include:

  • identifying opportunities for enhanced use of RWE throughout the product life cycle
  • mapping of potential RWE sources
  • analyzing existing regulations and developing considerations for potential new regulations
  • developing policy for a risk-based framework and potential new regulations
  • developing and implementing a RWE strategy for medical devices
  • consulting with stakeholders on:
    • the RWE strategy
    • new regulations
    • risk-based framework

We expect that work on all parts of the project will be complete by fall 2020.

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