International nomenclature implementation in European incident reporting with medical devices
Posted on 06.05.2020
The adverse event codes developed by the International Medical Device Regulators Forum (IMDRF) are being implemented in the European vigilance reporting when manufacturers inform competent authorities about incidents with medical devices including in vitro diagnostic medical devices.
Now a new set of IMDRF adverse event codes were published for Parts and components (Annex G) - available at the IMDRF website here – that completes the international nomenclature. The Annexes A-F were transformed into a new restructured layout which enables to produce machine-readable files (e.g. CSV) easier as compared to the previous format.
A searchable web-browser on all IMDRF Adverse Event terms/codes will be published soon at the IMDRF website to facilitate finding the appropriate codes.
The enforcement dates of the IMDRF Adverse Event codes for mandatory use in the European Manufacturer Incident Reporting form are summarised below:
Event-type - EU enforcement date: 1 January 2020
• Medical device problem codes and terms: Annex A + Annex A in new format + Annex A reference mapping
Evaluation / Cause investigation - EU enforcement date: 1 January 2020
• Type of investigation codes and terms: Annex B + Annex B in new format + Annex B reference mapping
• Investigation finding codes and terms: Annex C + Annex C in new format + Annex C reference mapping
• Investigation conclusion codes and terms: Annex D + Annex D in new format + Annex D reference mapping
Patient problem / Patient outcome - EU enforcement date: 1 June 2020
• Clinical sign, symptom and condition codes and terms: Annex E + Annex E in new format
• Health impact codes and terms: Annex F + Annex F in new format
Part and component - EU enforcement date: 1 May 2021
• Part and component codes and terms: Annex G in new format only