EU MDR: Field Safety Corrective Actions (FSCAs)

Under EU MDR Article 87, a Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce a risk of death or serious deterioration in health associated with a device already placed on the market. FSCAs include: device recalls (physical retrieval), device modifications, device replacements, device corrections (software updates, configuration changes), and advisory notices. FSCAs must be reported to the national competent authority (NCA) in each EU member state where affected devices are present. The manufacturer must also issue a Field Safety Notice (FSN) — a communication to customers describing the problem and required action.

EU MDR: Field Safety Notice (FSN) Requirements

The FSN is a formal written communication from the manufacturer to customers (distributors, healthcare facilities, and in some cases patients) describing the issue and required corrective action. The FSN must include: device identification (UDI, name, model, batch/lot numbers), description of the issue and associated risks, required actions (return, quarantine, correction, continue use with precautions), instructions for customers, contact information for queries, and a customer acknowledgement form. The FSN template should be pre-designed and pre-approved as part of your Quality Management System — creating it during a crisis adds unacceptable delay.

FDA: Recall Classification and Reporting

The FDA classifies recalls by risk: Class I (reasonable probability that the product will cause serious adverse health consequences or death), Class II (product may cause temporary adverse health consequences, or probability of serious adverse health consequences is remote), Class III (product is unlikely to cause any adverse health consequences). Manufacturers must report Class I and Class II recalls to the FDA. The FDA may also request a recall in cases where the manufacturer does not act voluntarily. All recalls are published in the FDA's public Recall Database — transparency is a fundamental part of the US system. Manufacturers must submit a recall strategy and status reports until the recall is terminated.

Traceability: Why UDI Makes Recalls Manageable

Effective recall execution depends entirely on traceability: knowing exactly which customers received which batch or serial numbers of an affected device. The UDI system — with lot-level or serial-level tracking — makes this possible. Manufacturers with complete UDI traceability in their ERP system can identify affected units, affected customers, and affected patients in hours rather than weeks. Manufacturers without UDI traceability face a far more complex, time-consuming, and reputationally damaging recall process. Post-MDR, UDI-enabled traceability is not just a regulatory requirement — it is a business continuity essential.

Vigilance Reporting: The Trigger for FSCAs

FSCAs are typically triggered by post-market vigilance events: customer complaints, serious adverse events, near-misses, or safety-related literature findings. EU MDR Articles 87–90 define the vigilance reporting timeline: serious incidents involving death or serious deterioration in health must be reported to NCAs within 15 days (or 24 hours for public health emergencies); trend reports for statistically significant increases in non-serious events are also required. Manufacturers must have a documented complaint handling and vigilance reporting procedure that integrates with the recall decision process — not treats it as a separate system.

Recall Procedure Checklist

Every manufacturer should have pre-established: ☑ Recall committee with defined roles (Quality, Regulatory, Operations, Legal, Communications) ☑ Recall decision criteria — defined thresholds for triggering FSCA ☑ FSN template pre-approved in multiple EU languages ☑ Customer database with device traceability by lot/serial number ☑ NCA notification templates for each EU member state ☑ FDA MedWatch reporting account established ☑ Media and communications holding statement prepared ☑ Recall status tracking system ☑ Mock recall drills conducted at least annually

Conclusion

Recalls are not a sign of failure — they are a sign of a functioning post-market surveillance system identifying and correcting risks before they become patient harm events. Turkish medical device manufacturers who invest in documented recall procedures, UDI-enabled traceability, and practised response protocols will manage recall events more effectively, maintain regulatory relationships, and protect their commercial reputation far better than those who treat recall preparedness as a theoretical exercise.