Field Safety Notices: Definition & Purpose

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.

MDR/IVDR Requirements about Field Safety Notices

Article 89(8) of the MDR and article 84(8) of the IVDR mention that the requirements concerning the Field Safety Notices.

Both articles have the same requirements.

In essence, the manufacturer shall be ensure that information about the field safety correction action (FSCA) taken is brought without delay to the attention of users of the device in questions by means of a field safety notice (FSN)

The FSN shall explain, in a clear manner, without understating the level of risk, the reasons for the FSCA, with the reference to the device malfunction and associated risk for patients, users or other persons, and shall clearly indicated all the actions to be taken by users.

The manufacturer shall enter the FSN electronically via EUDAMED, which allows the public to access the notice.

Comparison Table

EU MDR – Regulation (EU) 2017/745
EU IVDR – Regulation (EU) 2017/746

Article 89 – Paragraph 8

Analysis of serious incidents and field safety corrective actions

Article 84 – Paragraph 8

Analysis of serious incidents and field safety corrective actions

The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow it to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.

The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.

The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular, by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons, and shall clearly indicate all the actions to be taken by users.

The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons and shall clearly indicate all the actions to be taken by users.

The manufacturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that notice shall be accessible to the public.

The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which that notice shall be accessible to the public.

Recommended Reading

GHTF SG2/N57R8:2006 – Medical Devices Post Market Surveillance: Content of Field Safety Notices

Safety Information IMDRF web page

References

Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version)

Regulation (EU) 2017/746 IVDR: 02017R0746 — EN — 05.05.2017 — 000.003 (consolidated version)

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