Standardizing Adverse Event Reporting: IMDRF Terminology

Despite having been published over three years ago, many manufacturers marketing their devices in IMDRF within the subject of adverse event reporting, have still not applied for adverse terms, terminology structure, and codes established under the framework of IMDRF/AE WG/N43FINAL:2020 (Edition 4) and its corresponding annexes, as maintained on the IMDRF website.

Categorized adverse event reporting terminology under the IMDRF framework

In this article, we provide a brief overview of the IMDRF framework and its integration into QMS processes.

Adverse event terminology with codes and benefits

Vigilance requirements are one of the cornerstones of national device regulatory frameworks across the globe and are a means for stakeholders, including authorities and manufacturers, to monitor device safety and performance on an ongoing basis and identify risks to requiring corrective actions. However, as the respective national regulatory frameworks are established by each government and regulatory authority, historically there has been a lack of harmonization in how reportable events are identified/classified/categorized by these regulatory authorities. As a result, the IMDRF established a working group to develop harmonized terminology for reporting adverse events related to medical devices, including IVDs, intended for use by both reporters of adverse events and regulatory authorities. 

The IMDRF adverse event reporting terminology is comprised of seven sets of terminologies, including medical device problem terminology, components terminology, cause investigation terminology and health effects terminology. 

 Categories to describe:

• • The Medical Device Problem (IMDRF A) 
  • The Type of Investigation Performed (IMDRF B) 
  • The Investigation Findings (IMDRF C) 
  • The Investigation Conclusion (IMDRF D)  
  • The Health Effect – Clinical Signs and Symptoms or Conditions (IMDRF E) 
  • The Health Effect – Health Impact (IMDRF F) 
  • The Medical Device Component (IMDRF G)  

All of these IMDRF codes are to be included when reporting adverse events, as indicated in the figure below:

Event reporting terminology 

The medical device problem terms/codes are established under a three-level hierarchy in Annex A of the IMDRF document and are utilized for describing problems (malfunction, deterioration of function, failure) of devices that have occurred in pre- or post-market contexts without yet describing problems or failures observed. Examples include: 

There are three subsets of terms/codes established in Annexes B, C and D of the IMDRF document used for different elements of an investigation, including the type (Annex B), findings (Annex C) and conclusions (Annex D) of the investigation related to the root cause of the event. Examples include: 

In general, while filing an initial vigilance report manufacturers of devices are required to provide the IMDRF A, IMDRF E, and IMDRF F code to describe the reported incident. In a final report, also the IMDRF codes related to the cause investigation (I.e. IMDRF B, IMDRF C and IMDRF D) are required.  

The benefits in utilizing the IMDRF harmonized terminology include improving the accuracy of capturing and reporting data related to adverse events, reducing ambiguity and thereby increasing effectiveness of the investigation/evaluation process and compatibility with incident management systems including facilitating trend analysis (and reporting) processes. In particular, for manufacturers it allows for the establishment and application of consistent terminology when dealing with multiple global markets which can be used for both pre-market and post-market processes. In addition, for competent authorities harmonized terminology provides added value for their post-market surveillance activities and monitoring vigilance cases from their perspective. 

The utilization of IMDRF terms and codes in the QMS process

In its transition to the MDR/IVDR, the EU Commission has established a more robust regulatory framework focused on a total product lifecycle approach, with increased inter-relationship between the pre- and post-market product lifecycle phases. 

While the benefits in utilization of IMDRF terms/codes in vigilance reporting processes have been discussed above, these benefits also extend to other processes that are directly related to device vigilance reporting, including: 

Post-market surveillance (PMS)/Post-market clinical/performance follow-up (PMCF/PMPF) 

PMS includes the collection and utilization of information concerning serious incidents, including information from field safety corrective actions (FSCAs) and therefore, the utilization of the same IMDRF terms/codes used in the vigilance reporting process would ensure consistency in how such data is handled during PMS. This would also applyi the same terms/codes to the following PMS information sources: 

• • • • Data on undesirable side-effects 
      • Trend reporting 
      • Publicly available information about similar devices (such as data obtained from publicly available regulatory authority adverse event databases) 

The utilization of the IMDRF terms/codes would also fall within the scope of effective and appropriate methods and processes to assess the collected PMS data and investigate complaints and analyze market-related experience collected in the field and the importance of the use of the IMDRF terminology for consistent and harmonized reporting on post-market data is also stressed by the Medical Device Coordination Group (see MDCG 2022-21) 

Clinical/performance evaluation (CER/PER) 

PMS data falls within the scope of clinical evidence that should be assessed (where available) for devices as part of the clinical evaluation process under the MDR and performance evaluation process under the IVDR. This includes PMS data available for similar and/or equivalent devices, as applicable. However, clinical/performance evaluation also includes data from peer-reviewed scientific literature. Both literature and PMS data (such as adverse event database searches) are used to identify clinical risks related to device use in a clinical setting. Where possible, utilizing the IMDRF terms/codes for clinical risks (both the root cause and clinical impact) identified in both PMS and literature would also ensure consistency in risk identification across these different data types. For both the clinical and performance evaluation, it is essential that analysis of the data includes an analysis of how the clinical evidence demonstrates conformity with GSPR 1, which is strongly linked to the risk management process. 

Risk management 

When determining whether clinical evidence demonstrates conformity with GSPR 1 in clinical/performance evaluation, it is strongly recommended that manufacturers discuss the clinical risks identified in the literature and PMS data (and other clinical evidence sources) and how such risks have been addressed by the manufacturer’s risk management process. This can be done by including a matrix in the CER or PER that lists: each of the respective clinical risks identified in the clinical evidence, the identifier for the related risk/hazard in the device’s risk management file (RMF) (e.g. risk analysis hazard ID #), and a description of the risk controls implemented to address the hazard and reduce its risk level as far as possible (AFAP). This connection back to the RMF demonstrates the utility of IMDRF terms/codes when identifying hazards and their corresponding hazardous situations and consequences in the hazard/risk analysis. By doing so, manufacturers ensure utilization of consistent terminology from the beginning of device design (as the outputs of risk management are an element of design input). 

Design and development 

In addition to serving a purpose in design input, the utilization of IMDRF terms/codes have an important role to play in other design and development activities, primarily in design validation. For example, when realizing clinical investigations or clinical performance studies, the reporting of adverse events which occur during the realization of such studies would also ensure consistency with the approach taken post-market, ensuring that such information can be easily fed back into the risk management process utilizing the same approach used during initial hazard/risk analysis. 

IMDRF categorized adverse event reporting terminology with MedEnvoy

By integrating the utilization of the IMDRF terms/codes in the process described above, this would also ensure that for management processes, such as management review, adverse event/risk/hazard information is consistently described across the QMS processes reviewed. If you have any questions regarding device vigilance or other QMS processes, or require relevant training/consulting services, get in touch.

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