The International Medical Device Regulators Forum (IMDRF) published an updated version of the Adverse Event Reporting (AER) codes and terms on 2 March 2021. These codes/terms are to be used in the EU Vigilance reporting.
According to the release note for the IMDRF Terminology Edition 5.0, this edition incorporates the Change Requests received for the 2020 maintenance cycle as well as corrections of typos made by the working group prior to final publication.
Overview of changes:
- Annex A: Modified 2 terms (A0908, A15).
- Annex B: Added 1 new term (B23) and modified 1 term (B16).
- Annex C: Added 1 new term (C23) and modified 1 term (C19).
- Annex D: Added 4 new terms (D0107, D0108, D1501, D18) and modified 3 terms (D10, D1107, D12).
- Annex E: Added 2 new terms (E2120, E2342) and modified 23 terms (E0105, E010904, E0115, E0135, E0304, E0508, E0710, E0749, E082901, E0835, E0843, E1101, E1305, E1409, E1412, E1625, E1904, E1905, E2106, E2119, E231201, E231501, E2336).
- Annex F: Modified 5 terms (F14, F2204, F2305, F25, F26)
- Annex G: Modified 9 terms (G02011, G0201501, G02020, G03006, G0405202, G04095, G04130, G0600102, G0600601)
The deadline for Change Requests for the next maintenance cycle is 1 September 2021.
What does this mean to you?
As these codes have been incorporated into the Manufacturer Incident Reporting form, they are a vital element on your Vigilance reporting procedure. Therefore, it is vital that you as a company ensure that you are working with the latest available codes.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.