MDCG Guidances on vigilance system for CE-marked devices

The Medical Devices Coordination Group (MDCG) has released a new set of guidances on the vigilance systems for CE-marked devices. As such, a template is provided on Device Specific Vigilance Guidance (DSVG), which focuses on the following topics:

  • What should be reported, with a focus on individual serious incidents, Periodic Summary Reporting (PSR) and trend reporting
  • DSVG examples
  • Clinical references and clinical guidelines
  • IMDRF terminologies for categorised adverse event reporting

Moreover, the MDCG released several device-specific guidances, focusing on the following categories:

You can read these and other relevant MDCG Guidances in our MDCG section in MDlaw!

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