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Related Experiment Videos

New medical device regulations: the regulator's view.

Tom Melvin1, Marina Torre2

  • 1Medical Officer, Health Products Regulatory Authority, Dublin, Republic of Ireland.

EFORT Open Reviews
|July 18, 2019
PubMed
Summary

New European regulations mandate registries for medical device manufacturers to systematically track safety and performance post-market. These registries are crucial for public health and gathering real-world clinical evidence beyond traditional studies.

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Area of Science:

  • Medical device technology
  • Regulatory affairs
  • Public health

Background:

  • Medical device technology has advanced significantly, leading to more complex and critical devices.
  • European regulations, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR), were introduced in May 2017.
  • These new regulations mandate the use of registries for medical devices.

Purpose of the Study:

  • To highlight the importance of registries in the context of new European medical device regulations.
  • To explain the role of registries in post-market surveillance and real-world evidence generation.
  • To emphasize how registries can enhance patient safety and device performance monitoring.

Main Methods:

  • Systematic data gathering, recording, and analysis of medical device safety and performance.
Keywords:
EU regulationsmedical deviceregistry

Related Experiment Videos

  • Leveraging registries for post-market surveillance and real-world data collection.
  • Comparing registry data with clinical investigation data and pooling information.

    • Main Results:

    • Registries provide practical public health benefits, such as rapid patient and device identification.
    • Registries are powerful tools for appraising real-world clinical evidence, complementing limited clinical investigations.
    • Registries enable the study of rare adverse effects, specific sub-populations, and long-term outcomes.

    Conclusions:

    • Registries are essential for fulfilling new regulatory requirements for medical device manufacturers.
    • Registry data significantly enhances the understanding of medical device safety and effectiveness in real-world settings.
    • Collaborative initiatives are crucial for ensuring the appropriate regulatory application of registry data.