MDR Reportable Event definition
MDR Reportable Event means (a) an event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or Serious Injury, or (b) an event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices: (i) may have caused or contributed to a death or Serious Injury, or (ii) has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or Serious Injury if the malfunction were to recur.
Examples of MDR Reportable Event in a sentence
For Aerogen’s performance of its obligations under this Article 5.6, the term “adverse event” shall be interpreted as either an MDR Reportable Event or Incident, where these terms shall have the meanings set forth in the IS 21 CFR 803 and the European Medical Device Directive 93/42/EEC Article 10, respectively.