In the rapidly evolving landscape of medical devices, patient safety takes precedence. When issues that could potentially pose risks to users and patients arise with a medical device, manufacturers must take swift corrective action. One essential tool in this process is the Field Safety Notice, a communication mechanism used by manufacturers to inform users and customers about safety concerns regarding their products. In this article, we explore the concept of Field Safety Notices, and discuss the mandatory language requirements applicable to them under the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR).
What are the medical device vigilance reporting requirements under the EU MDR and IVDR?
To ensure a structured and transparent approach to addressing safety concerns associated with medical devices across the EU, the MDR and IVDR establish a mandatory incident reporting mechanism. Medical device and IVD companies must follow this mechanism when a serious safety issue is identified with their products post-market release.
Manufacturers must thoroughly investigate all incidents related to their medical devices. Article 2(64) of the MDR and Article 2(67) of the IVDR define an incident as any device malfunction or deterioration in device performance or characteristics, as well as errors in the use of the device arising from its design features or inadequate instructions for use or labelling. An incident fulfils the definition of ‘serious’ when it results in death or serious deterioration of a person’s state of health, or a serious public health threat. In cases where no causal relationship between the device and the serious incident is established, the event is not considered a reportable serious incident. In accordance with Article 87 of the MDR and Article 84 of the IVDR, all serious incidents within the EU must be reported to the competent authority (CA) of the Member State where the incident occurred within the applicable reporting timescale. As of January 2020, this has to be done via a Manufacturer’s Incident Report (MIR) form. Based on a risk and root cause analysis of the event, the manufacturer may decide to take a field safety corrective action (FSCA), such as a recall or software update, to mitigate existing risks and/or to prevent reoccurrence. In this case, an FSCA report must be distributed to the CAs where the FSCA is taken. Furthermore, manufacturers must identify affected users and/or customers, and communicate the FSCA to them via a Field Safety Notice.
The MDCG 2023-3 Q&A on vigilance terms and concepts document, which replaced MEDDEV 2/12-1 rev. 8, offers manufacturers valuable information on vigilance terminology and reporting requirements.
What is a Field Safety Notice for a medical device?
Field Safety Notices, known as FSNs, play a pivotal role in the vigilance requirements. FSNs are official communications issued by medical device manufacturers to alert customers and users of the affected products about FSCAs taken in relation to them.
The EU MDR and EU IVDR define an FSN as follows:
EU MDR, Article 2(69)
EU IVDR, Article 2(72)
‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action
Many CAs maintain publicly accessible FSN databases that detail the FSCAs undertaken within their respective national markets.
How is the Field Safety Notice regulated by MDR Article 89 and IVDR Article 84?
Article 89(8) of the MDR and Article 84(8) of the IVDR are the linchpins that regulate the issuance and management of the FSN. These articles, sharing identical wording, place the responsibility on manufacturers to promptly issue an FSN, in order to alert users of the affected devices about an FSCA undertaken.
EU MDR, Article 89(8)
EU IVDR, Article 84(8)
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. […]
Typically, unless an FSN requires an urgent attention, a draft of the FSN is first submitted to the coordinating (or evaluating) CA for evaluation. As part of their Standard Operating Procedure (SOP), manufacturers should identify affected users and/or customers who will receive the FSN. Customers should confirm the receipt of the FSN as well as the implementation of recommended FSCA, if applicable. When the European database on medical devices (Eudamed) becomes fully functional (which is projected for the second quarter of 2024), manufacturers will enter their FSNs in its electronic vigilance and post-market surveillance system referred to in Article 92 of the MDR and Article 87 of the IVDR. This will make the FSNs available to the relevant CAs. Healthcare professionals and the public will also have appropriate levels of access to the system.
The content of an FSN is of critical importance and must include the following elements:
- Unique Device Identifiers (UDIs) to facilitate the identification of the device or devices involved;
- Single Registration Number (SRN) to identify the manufacturer executing the FSCA;
- Reasons for the FSCA, with reference to the device malfunction and associated risks to patients, users, or others;
- Clear indication of all the actions recommended to the user.
What is the Field Safety Notice template?
While Article 89(8) of the MDR and Article 84(8) of the IVDR outline mandatory elements to be included in the FSN, they do not specify its exact content. However, they do state that, unless duly justified by the situation of the individual Member State (e.g. a translation error in the instructions for use that appears only in certain languages and therefore affects only specific countries), the FSN should be consistent in content across the affected EU Member States. To support this uniformity, the European Commission has developed a standardised FSN form intended for communicating FSCAs to healthcare professionals. In the Q&A guidance document available on the European Commission’s website, the European Commission clarifies that although this FSN template cannot be mandatory as it is not defined within the MDR or IVDR, its use is strongly encouraged in the interest of public health and for the sake of consistency.
Field Safety Notice template with instructionsDownload
What are the MDR and IVDR language requirements for Field Safety Notices?
The MDR and IVDR make language requirements compulsory for certain information provided with the medical device, such as the labelling and instructions for use, and the declaration of conformity. Therefore, such information must be presented in the language(s) specified by the Member State in which the device is made available to the user or patient.
These national language requirements extend to the FSN as well. The MDR and IVDR require that the FSN should be prepared in the official EU language(s) specified by the Member State in which the FSCA is taken.
EU MDR, Article 89(8)
EU IVDR, Article 84(8)
[…] 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. […]
Adhering to these language mandates is essential for manufacturers to effectively communicate device-related safety information and fulfil their obligations under the MDR and IVDR.
What are the EU languages accepted for Field Safety Notices in the EU countries?
Within the EU, there are 24 official EU languages. Since FSNs contain safety information intended for the end-user, most EU Member States require that they are presented in their official national language(s).
|EU Member State||Language(s) for Lay Users||Language(s) for Professional Users|
|Belgium||Dutch and French and German||English; Dutch or French or German upon request|
|Cyprus||Greek||Greek or English|
|Estonia||Estonian; English acceptable if urgent||Estonian; English acceptable if urgent|
|Finland||Finnish and Swedish or other language(s) necessary for safety||Finnish and Swedish or other language(s) necessary for safety|
|Ireland||English or Irish and English||English or Irish and English|
|Luxembourg||French or German or Luxembourgish||French or German or Luxembourgish|
|Malta||English or Maltese or English and Maltese||English or Maltese or English and Maltese|
|Netherlands||Dutch or English||Dutch or English|
|Romania||English and Romanian||English and Romanian|
Where can medical device manufacturers find translations of the Field Safety Notice (FSN) template?
The official FSN template, published by the European Commission and intended for healthcare professionals, is available only in English. Manufacturers who need the FSN template in other EU languages, can purchase these directly from our online store. Professionally translated with the use of MDR and IVDR terminology, and available in a selection of languages including French, German, Italian, and Spanish, these language versions serve as indispensable tools for manufacturers and their representatives who wish to streamline their vigilance reporting processes with confidence.
Please note that the information provided in this article relating to medical device safety, reporting of serious incidents, field safety corrective action, and field safety notice in accordance with Article 89 of the MDR and Article 84 of the IVDR, is for guidance only and does not constitute professional regulatory advice. In the case of specific questions related to regulatory compliance, we recommend seeking assistance from a QA/RA specialist or a relevant Competent Authority of the Member State.