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A Field Safety Notice (FSN) is a communication tool issued by medical device manufacturers to inform users and regulatory authorities about a problem with a device, including potential risks and recommended actions. According to the European Commission (ECs) Guidance document on Market Surveillance- Guidelines on a Medical Devices Vigilance System -MEDDEV 2.12/1 rev.8, a FSN is “a communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.”. The importance of FSNs lies in their role in maintaining patient safety and regulatory compliance. By promptly alerting healthcare providers to risks, FSNs facilitate quick action to mitigate adverse effects, ensuring the continuous safe use of Medical Device Regulation.

What should a manufacturer include in a Field Safety Notice?

A manufacturer should offer a uniform and consistent FSN to all affected EEA Member States, Switzerland, and Turkey. The FSN should be on the manufacturing company letter head and in the language/s accepted by the National Competent Authority (NCA). It should include a clear title, name of the affected product, date of Field Safety Corrective Action (FSCA), and type of action.

It should also include information that would help in the identification of the product. This could be type of device, name & number of model, batch/lot of serial numbers etc. It should also include a statement, supported with facts, that explain the reason behind the FSCA such as description of device malfunction, associated risk to the patient/user. It should also have any advice that the user must take and request to pass the FSN to those who need to be aware.

The FSN should also include confirmation that the relevant NCA has been advised/informed of the FSCA, and not include comments & descriptions which would downplay the risk level and advertise the product. Finally, the FSN should include the contact point/designated that customers can reach out to. The template for an FSN is provided in Annex 5 of the Market Surveillance- Guidelines on a Medical Devices Vigilance System -MEDDEV 2.12/1 rev.8.

Conclusion

Overall, FSNs are a critical component of the healthcare system’s safety and regulatory affairs services framework. They ensure that healthcare providers are informed about potential risks associated with medical devices, enabling timely and appropriate actions to protect patient safety. The effectiveness of FSNs relies on the cooperation between manufacturers, regulatory authorities, and healthcare providers to ensure the swift dissemination and execution of the recommended actions.

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