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Homepage Pharmaceutical Industry Medical devices Vigilance Reporting – Medical Devices Field Safety Corrective Action (FSCA) Reporting

Field Safety Corrective Action (FSCA) Reporting

Definition of Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action (FSCA) is defined in Article 2(68) of Regulation (EU) 2017/745 on medical devices (MDR) and Article 2(71) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident related to a device made available on the market.

An FSCA may include, for example:

  • returning the device to the distributor,
  • modifying or replacing the device,
  • or other actions taken by the manufacturer.

Definition of Field Safety Notice (FSN)

A Field Safety Notice (FSN) is defined in Article 2(69) of the MDR and Article 2(72) of the IVDR as a communication sent by the manufacturer to users or customers in connection with a Field Safety Corrective Action.

Manufacturer’s Obligations to Report an FSCA

According to Article 87(1)(b) of the MDR and Article 82(1)(b) of the IVDR, manufacturers must report every FSCA to the competent authority. This includes any FSCA taken by a third country concerning a device that is also legally placed on the Union market, if the reason for the FSCA is not limited to devices made available in the third country.

The report must be submitted through the Eudamed database as referred to in Article 92 of the MDR and Article 87 of the IVDR.

In urgent cases, where immediate action is required to protect health or safety, the FSCA must be implemented without delay. The manufacturer is still required to notify the competent authority as soon as possible.

Until the Eudamed database is fully operational (in line with Article 34 of the MDR), reporting and information exchange obligations follow:

  • Directive 90/385/EEC on active implantable medical devices,
  • Directive 93/42/EEC on medical devices,
  • Directive 98/79/EC on in vitro diagnostic medical devices (for IVDR transitional requirements).

These apply according to transitional provisions:

  • Article 123(3)(d) MDR,
  • Article 113(3)(f) IVDR.
  • Manufacturers who perform or intend to perform a Field Safety Corrective Action in the Czech Republic.
  • Manufacturers with a registered place of business in the Czech Republic.

Manufacturers must submit reports electronically using the Field Safety Corrective Action Report Form, filled out and signed with a recognized electronic signature, in accordance with the European Commission’s vigilance guidelines.

Submission Format

Reports must be sent to SÚKL in PDF format, together with the XML data file.

Submission Channels

Report Types

SÚKL also accepts reports submitted using the form from the European Union Medical Devices Vigilance System guidelines (MEDDEV 2.12-1). These reports must be submitted in PDF format along with the XML data file, both signed with a recognized electronic signature.

The FSN must be submitted to SÚKL in Czech and English.

In accordance with Article 89(8) of the MDR and Article 84(8) of the IVDR, the FSN must:

  • Ensure correct identification of the affected device(s), including the relevant UDI-DI (Unique Device Identification – Device Identifier),
  • Include the identification of the manufacturer who implemented the FSCA, including the Single Registration Number (SRN), if available,
  • Clearly explain the reason for the FSCA, without minimizing the level of risk, referring to the device malfunction and associated risks for patients, users, or others,
  • Clearly state the actions that users must take.

Field Safety Notice Form (available in Czech and English) – using of these forms are not mandatory

Currently, FSNs are not made available to the public through the Eudamed database.