The Medical Device Reporting (MDR) Regulation (21 CFR 803) requires that all manufacturers report to FDA whenever a device:
  • may have caused or contributed to a death or serious injury or

  • has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

GEMAR is prepared to assist you in deciding what is required to be reported and how soon it is required to be reported, as well as what form the information should be submitted on. We can also assist you in developing, maintaining, and implementing written MDR procedures for your company - contact us for further information.