IMDRF codes
The International Medical Device Regulators Forum (IMDRF), in collaboration with manufacturers and regulatory authorities, has developed an internationally used code set for reporting incidents. The purpose of the code set is to clarify the reporting of device problems, to improve the detection of incidents, and to enable the statistical processing of the accumulated material.
The code set is divided into sub-areas
- Medical Device Problem
- Cause Investigation – Type of Investigation
- Cause Investigation – Investigation Findings
- Cause Investigation – Investigation Conclusion
- Health Effects – Clinical Signs and Symptoms or Conditions
- Health Effects – Health Impact
- Medical Device Component