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medical device registry

IMDRF Pushes Wider Use of Registry Data in Medical Device Regulatory Decisions

EMERGO SUMMARY OF KEY POINTS:

  • The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on recommendations for assessing usability of medical device registry data by regulatory agencies.
  • IMDRF identifies four key factors agencies should consider when determining the usability of a device registry’s data in making regulatory decisions.
  • IMDRF is accepting comment on its proposal until December 1, 2017.