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Belgium: New nomenclature for incidents with medical devices

09 January 2020

A group of the International Medical Device Regulators Forum (IMDRF) has recently developed a new nomenclature for the reporting of incidents with medical devices, which will become applicable in 2020.

The newly introduced codes will be used primarily to complete medical device reports (MDRs). They will therefore already form part of the new incident report form for manufacturers. More information about the new MDR form can be found on the European Commission's webpage that is dedicated to guidance on medical devices.

The IMDRF has so far developed and published the following sets of new nomenclature:

  • Terms and codes for problems with medical devices (annex A).
  • Terms and codes for the type of investigation into the cause of the problem (annex B).
  • Terms and codes for the results of the investigation (annex C).
  • Terms and codes for the conclusion of the investigation (annex D).
  • 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)

The codes in annexes A, B, C and D shall be mandatory from 1 January 2020 onwards and those in annexes E and F from June 2020 onwards. The nomenclature codes to indicate failed components (annex G) are still in development and are expected mid-2020.

The new nomenclature shall be mandatory for manufacturers who report incidents using a European report form. Other actors of the sector, such as distributors, health care professionals and patients, may choose to use the new nomenclature codes but will not be obliged to do so.

The Federal Agency for Medicines and Health Products advises manufacturers of medical devices to change their internal codes to the new nomenclature codes immediately. The information necessary for the implementation of the new nomenclature can be found on the IMDRF website.

This article was co-authored by Eveline Van Keymeulen.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2020 Issue (Thomson Reuters).