About the IMDRF
The International Medical Device Regulators Forum, or IMDRF, was established in October 2011 and is the successor to the Global Harmonization Task Force (GHTF), which was closed in 2012. The IMDRF is composed of medical device regulators from around the world to promote international convergence and harmonization of medical device regulations. Current members are Australia, Brazil, Canada, China, Japan, Russia, Singapore, South Korea, the United Kingdom, the United States, and the European Union. Current IMDRF working groups include:
Adverse Event Terminology
Artificial Intelligence/ Machine Learning-enabled
Good Regulatory Review Practices
Personalized Medical Devices (PMD)
Quality Management Systems
Regulated Product Submission
Software as a Medical Device
The working groups draw on the expertise of various stakeholders such as industry, academia, healthcare professionals, consumer and patient groups. The working group on Adverse Event Terminology developed a uniform terminology and a standardized approach for describing information on incidents involving medical devices - the IMDRF-codes.
Implementation of the IMDRF-codes
The IMDRF codes, also known as "Terminologies for Categorized Adverse Event Reporting", are divided into four areas and comprise seven subgroups, which are referred to as Annexes A to G. The areas and subgroups are divided as follows:
IMDFR area | Associated subgroups |
Medical Device Problem | Medical device problem (Anhang A) |
Cause Investigation | Type of investigation (Anhang B) |
Health Effects | Clinicals signs, symptoms and conditions (Anhang E) |
Component | Componens and parts (Anhang G) |
Annex A contains terms and codes to describe problems associated with a medical device, for example malfunctions, malfunctions or failures that have occurred with medical devices.
Annexes B, C and D refer to the investigation of the cause of the incident. Annex B contains terms and codes to describe the type of investigation that was carried out in the course of the incident (on the device). The terms and codes in Annex C are used to describe the results of the investigation carried out and the terms and codes in Annex D are used to describe the conclusion drawn from the investigations carried out.
The terms and codes in Annexes E and F are used to describe the effect on affected patients, users or third parties. Annex E contains terms and codes to describe the health effects on the affected person and Annex F contains terms and codes to describe the health consequences of the adverse event of a medical device for the affected person.
Finally, Annex G contains terms and codes to describe the parts/components involved in or affected by the incident.
At least one code is assigned in each subgroup to characterize a case. The individual codes always consist of a letter followed by a sequence of numbers. The letter corresponds to the letter of the associated subgroup/appendix. The numbers refer to the internal hierarchy of the annexes. The annex-internal hierarchy can be up to three levels deep. As the level depth increases, the facts become more specific. This can result in the following hierarchy, as shown here as an example from Appendix A:
Level 1:
A07 Electrical /Electronic Property Problem
Level 2:
A0705 Battery Problem
Level 3:
A070501 Battery Problem: High Impedance
A070502 Battery Problem: Low Impedance
A070503 Failure to Run on Battery
A070504 Premature Discharge of Battery
It is recommended that an incident be coded in as much detail as possible. However, depending on the data situation, it may only be possible to assign the level 2 or level 1 code with sufficient certainty. In practice, several codes from an appendix are often used in combination in order to describe the incident appropriately.
The current annexes with a detailed list of codes and definitions/help texts can be found on the IMDRF website.
Importance of IMDRF-codes for medical device manufacturers
The IMDRF-codes play an important role in the manufacturer's post-market surveillance and vigilance system. The Manufacturer Incident Report (MIR) form for reporting serious incidents in the European Union mandatorily introduces the use of the IMDRF-codes.
In addition, the IMDFR-codes can simplify the internal company search and evaluation of cases. The IMDRF codes can thus be used to identify comparable incidents, which must also be reported in the course of reporting serious incidents, and for trend analysis, which is required under MDR Article 88. In addition, the guidance regarding the Periodic Safety Update Report (PSUR) (MDCG 2022-21) refers to the use of IMDRF-codes in the course of PSUR preparation.
IMDRF-codes offers global manufacturers in particular support in communicating incidents involving medical devices.
