Table 1- Overview of the four sets of terminologies comprising the complete terminology for adverse event reporting
|No.||Name of terminology||Description||Annex||Coding system||Requested on the MIR form|
|1||Medical device problem||Terms/codes for describing problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or post-market contexts (e.g. clinical studies, clinical evaluation or post-market surveillance)||A||A|00||Section 3.2|
- Type of Investigation
|Terms/codes for describing the type of investigation of the device involved in the reported event.||B||B|00||Section 4.2|
- Investigation Findings
|Terms/codes for describing the findings of the device involved in the reported event.||C||C|00||Section 4.2|
- Investigation Conclusion
|Terms/codes for describing the conclusion of the device involved in the reported event.||D||D|00||Section 4.2|
- Clinical Signs, Symptoms and Conditions
|Terms/codes for describing the clinical signs, symptoms and conditions of the affected person appearing as a result of the medical device adverse event/incident.||E||E|00||Section 3.3|
- Health Impact
|Terms/codes for describing the consequences of the medical device adverse||F||F|00||Section 3.3|
|4||Component||Terms/codes for describing the parts and components which were involved in, or affected by, the medical device adverse event/incident.||G||G|00||Section 4.2|
The IMDRF Adverse Event Terminology working group published on 20th April 2020 a revised list of all the IMDRF nomenclatures which have been adopted. It now also includes Annex G (component codes).
The revised list of IMDRF codes can be found here.
As you may expect, the adverse event terminology will need periodic review and maintenance due to the nature of the medical device industry and implementation of the new technologies, materials, designs, procedures etc. However, frequent changes to the terminology are not anticipated and should be restricted to the absolute necessary (e.g. new terms for new devices, designs or materials).
Annex G – component codes
As stated on the IMDRF document “IMDRF/AE WG/N43FINAL:2020 (Edition 4)” from March 18th 2020, the terms listed on Annex G allow capturing of the specific part or component of the medical device which was involved in the incident. The component terms are grouped into sections to help the user to find an appropriate term. Each term appears in only one section, and some simple rules were applied in order to choose the appropriate section in cases where a term could logically fit into more than one section.
Components which have multiple attributes have been allocated to a section in the following order of preference:
Safety > Measurement > Optical > Biological & Chemical > Electrical & Magnetic > Mechanical
There will be some devices and/or incidents where it is not necessary or appropriate to select an individual component. The terminology includes a term /code to capture these cases, so it is possible for jurisdictions to make it mandatory that a report includes at least one term /code from each and every annex.
We hope this information is helpful. For more details, please do not hesitate to contact MDSS.