From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical product to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes.
The new nomenclature was developed by an international working group which is part of the International Medical Device Regulators Forum (IMDRF). It is meant to help European authorities authorised for medical devices in signal detection and help to analyse trends in incidents with medical devices.
On MRI form for reporting incidents
The codes of the new nomenclature will be introduced in the new incident report form for manufacturers, the so-called MIR form. The MIR form also contains additional information about trend data: the number of similar incidents in relation to the number of medical devices on the market. As of 1 January 2020, manufacturers will be required to use the MIR form to report incidents to the FAMHP. You can find more information about the new MIR form on the website of the European Commission (Guidance MEDDEVs > 2.12 Post-Market surveillance).
Only required for manufacturers>
The nomenclature codes and trend data are only obligatory for manufacturers reporting incidents using a European report form. Distributors, health care professionals and patients who report incidents via the FAMHP’s incident form are not obliged to use the new nomenclature codes. They may do so if they want to. The codes can facilitate communications between health care facilities, distributors and manufacturers.
Change internal codes now
The FAMHP strongly advises manufacturers to change their internal codes to the new IMDRF codes as of now. The IMDRF provides some tables to implement the FDA, NCI and ISO codes:
- terms and codes for problems with medical devices (annex A) + reference mapping
- terms and codes for the type of investigation into the cause of the problem (annex B) + reference mapping
- terms and codes for the results of the investigation (annex C) + reference mapping
- terms and codes for the conclusion of the investigation (annex D) + reference mapping
- terms and codes for clinical signals, symptoms and condition of patients (annex E)
- terms and codes for the impact on the health of patients (annex F)
Manufacturers must use the codes in annexes A, B, C and D starting 1 January 2020, and those in annexes E and F from June 2020. The nomenclature codes to indicate failed components (annex G) are still in development and are expected mid-2020. When they are available, manufacturers will have a year to adapt their codes. After that, the codes from annex G must also be used for reporting an incident.