Section 2
Requires the submitter to provide the relevant medical device information, such as i.a. UDI, nomenclature, device catalogue number, lot number, risk class and accessories or associated devices.
Section 3
Requires the submitter to provide specific incident information such as i.a. the nature of the incident, IMDRF Medical Device problem code (Annex A) and IMDRF “Health Effect” terms and codes (Annex E and F). Note that the IMDRF terminologies for categorized Adverse Event Reporting (AER) Annex E and F are not yet published.
Section 4
Requires the submitter to provide the manufacturer’s analysis, including the cause investigation and conclusion as well as the respective IMDRF “Cause Investigation” terms and codes (Annex B, C and D) and the IMDRF Component Codes (Annex G). Note that the IMDRF AER Annex G is not yet published.
Section 5
Allows for additional comments to be provided.