Incidents with medical devices: novelties
From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical product to the FAMHP. The new nomenclature has been developed by the IMDRF Adverse Event Working Group which is part of the International Medical Device Regulators Forum (IMDRF).
MIR form for reporting incidents
The codes of the new nomenclature will be introduced in the new Manufacturer Incident Report (MIR) form, which also includes the information about trend data. MIR form shall be mandatorily used from 1 January 2020, while the nomenclature codes and trend data are only mandatory for manufacturers reporting incidents using a European report form. For more information consult the Guidelines on a Medical Devices Vigilance System of the European Commission.
Changing the codes now
Distributors, health care professionals and patients who report incidents via the FAMHP’s incident form may use the new nomenclature codes if they want to, however 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 terms and codes related to
- Problems with medical devices (link is external) (annex A) + reference mapping
- Type of investigation into the cause of the problem (link is external) (annex B) + reference mapping
- Results of the investigation (link is external) (annex C) + reference mapping
- Conclusion of the investigation (link is external) (annex D) + reference mapping
- Clinical signals, symptoms and condition of patients (annex E)
- Impact on the health of patients (annex F)
Codes in annexes A, B, C and D are to be used 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. Once available, manufacturers will have a year to adapt their codes.
Deputy Manager - VIP Deparment
If you wish to have more information about the new Nomenclature, Obelis Expert Consultants, with more than 30 years of experience with EU regulatory affairs, will gladly answer your questions and assist you in ensuring compliance of your IVD medical devices.Get in touch