The IMDRF revised the IMDRF codes on2nd March 2021. These can now be used for Adverse Event Reporting.
The codes are divided into the following six categories:
- problem
- type of investigation
- investigation findings
- investigation conclusion
- clinical signs, symptoms and conditions
- health impact
At least one code must be set per category. In their entirety, the codes describe the incident (1, 5 and 6) and the investigation (2 to 4). Already in September 2020, the US FDA harmonized the coding system of the electronic Medical Device Reporting (eMDR) system with the IMDRF codes, which can be now directly used.
The reporting system in Germany also uses the IMDRF codes. However, at this point in time, the Bfarm is still using the previous IMDRF codes from April 2020 in the MIR - Manufacturer Incident Report. However, it is expected that the codes will also be updated in Germany.
Furthermore, the reporting system in Europe will almost certainly require the IMDRF codes. According to MDCG 2018-2, EUDAMED should use an internationally recognized nomenclature, explicitly referencing the work of IMDRF and the World Health Organization (WHO). The aim of the IMDRF is to promote the harmonization of internationally different regulations.
Have your internal processes already been checked to see if this innovation will affect your quality management system? Also think about your trending if you use the IMDRF codes!
In view of the innovations, gempex offers a free initial consultation!
Based on reliable regulatory and practical expertise, the Medical Devices Team is available for a compact check or to answer specific questions and provide initial advice.
If you are interested, please contact Frank Studt, Managing Director gempex, to arrange an appointment via contact@gempex.com.