The Field Safety Notices under the MDR and the IVDR (Art. 89(8)/84(8))

A Field Safety Notice (FSN) is defined in the MDR and IVDR as communication sent by a manufacturer to users or customers in relation to a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

In this context, the corrective action taken is called Field Safety Corrective Action (FSCA).

The serious incident mentioned above can be referred as any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect; that directly or indirectly led, might have led or might lead to any of the following:

(a) the death of a patient, user or other person,

(b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,

(c) a serious public health threat  – meaning an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.