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.
- By typing text in the free text field, elements not matching the text are removed. The text inserted is searched in all the fields composing each term. The text found is highlighted in red.
- The button "Expand all/Collapse all" allows to collapse or collapse all the terms in order to visualize the entire structure.
- To reset the search and restore the initial status of the IMDRF web browser, click the Reset button.
- 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