From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical device to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes.

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.


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