Annex F: Health Effects - Health Impact
Release Number: 2025
Working Group
Notes on using these annexes:
- Wherever appropriate, the word 'device' should be interpreted as meaning all or any of the following: medical device, in-vitro diagnostic medical device, accessory to a medical device, medical device parts and/or components.
- Wherever appropriate, the word 'patient' should be interpreted as meaning all or any of the following: user, operator, any other person affected by the incident.
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- IMDRF Terms and Definitions use American spelling.
Other Annexes in the Adverse Event Terminology Web Browser
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