Reporting of field safety corrective actions and field safety notices

Which devices and products are subject to the requirements on reporting?

The following device categories are subject to the requirements on the reporting of serious incidents:

• all CE-marked medical devices, in vitro diagnostic medical devices, and active implantable medical devices (AIMD) – including accessories, systems and procedure packs
• custom-made medical devices
• nationella medicinska informationssystem (NMI) – certain non-medical device software products covered by national legislation.

Serious adverse effects (SAE) with the following device categories shall be reported within the framework of the clinical investigation or the performance study:

• investigational devices - medical devices without CE-mark manufactured with the purpose of performing a clinical investigation
• in vitro diagnostic medical devices without CE-mark manufactured with the purpose to perfom a performance study.

Requirements on reporting

As a manufacturer, you shall submit reports on FSCA and FSN to Läkemedelsverket (Swedish MPA).

The definition of the corrective actions that are considered as FSCA are somewhat different between MDR/IVDR and the directive-based legislation. In practice, the differences in the handling of FSCA/FSN between different device categories are minor.

Devices according to the full requirements of MDR/IVDR

You shall submit reports on field safety corrective actions (FSCA) and field safety notices (FSN) to Läkemedelsverket (Swedish MPA).

Definition of field safety corrective action (FSCA): corrective action taken by a 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.

Definition of field safety notice (FSN): a communication sent by a manufacturer to users or customers in relation to a field safety corrective actio

The requirements on reporting of incidents are laid down on article 89 in MDR and article 84 in IVDR respectively. National provisions on the process of reporting until Eudamed is fully functional are laid down in HSLF-FS 2021:32.

“Legacy devices” – devices subject to the transitional provisions

Manufacturers that have placed legacy devices on the marker after 26 May 2021 (MDR) or 26 May 2022 (IVDR) according to the transitional provisions are subject to the requirements on reporting, including FSCA and FSN, in MDR and IVDR respectively.

“Old devices” – devices placed on the market prior to MDR/IVDR

Devices placed on the market according to the directive-based legislation prior to the date of application of MDR/IVDR – ”old devices” – are subject to the requirements on reporting, including FSCA and FSN, in the directive-based legislation.

Formally, the legal requirements on incident reporting and the legal definition of the reportable incident are in Swedish national legislation only available in Swedish. However, the national provisions have the same meaning as the definitions (see paragraph 4.6 and 4.7) and the procedures described in MEDDEV 2.12/1, rev 8.

Custom-made devices

Incidents involving custom-made devices shall be reported, including FSCA and FSN, in the same manner as CE-marked medical devices according to MDR (custom-made devices that left the manufacturer from 26 May 2021) or as “old devices” (custom-made devices that left the manufacturer prior to 26 May 2021) respectively.

Nationella medicinska informationssystem (NMI)

FSCA and FSN regarding Nationella medicinska informationssystem (NMI) placed on the market according to the requirements in the new legislation (HSLF-FS 2022:42) shall be reported in the same manner as devices according to MDR.

FSCA and FSN regarding NMI placed on the market according to the requirements in the old legislation (LVFS 2014:7) shall formally be reported in the same manner as ”old devices” (see also bilaga 2 to the guidance document on NMI, only in Swedish). However, the transitional provisions for NMI:s laid down in the new legislation (HSLF-FS 2022:42) states that the reporting of incidents preferably should be performed according to the requirements in MDR.

Who shall report to Swedish MPA?

Manufacturers that are established in Sweden shall always submit FSCA reports and FSN to Swedish MPA, it does not matter if the concerned devices are or have been made available on the Swedish market or not. These manufacturers shall also submit FSCA reports and FSN to the competent authorities in all member states where the devices are or have been made available on the market. Contact points for all competent authorities is available on the website of the EU Commission.

Manufacturers that are established outside of Sweden shall submit FSCA reports and FSN to Swedish MPA if the concerned devices are or have been made available on the Swedish market.

What shall be reported by the manufacturer?

Field safety corrective action (FSCA) report

The FSCA report shall contain appropriate parts of the risk assessment as well as background information and the reasons for the FSCA. This includes descriptions of

• the device malfunction and/or deterioration of safety/performance
• the risks for patients, users and other persons associated with any further use of the device
• any possible risks for patients associated with previous use of the device.

The FSCA report shall, whenever possible, use the commonly agreed template that is available from the website of the EU Commission.

Save the report in both PDF and XML from the report template

When you have completed the appropriate data in the the template to complete the FSCA report, save the report in PDF and XML format. Please note that you should save in both formats before closing the document as not all functionality is retained in the saved version.

Saving in PDF format:

• Use the function to save as a PDF file in your PDF reader software.
• Choose where to save the PDF document.
• Save the PDF document.

Saving in XML format:

• Use the button ”send XML-data by E-Mail” that is available at the bottom of the template.

• An e-mail draft with the XML document as an attachment is opened in your e-mail client software.
• Specify an e-mailaddress (e.g. your own address) as the recipient and send the e-mail message.
• Save the XML document attachment from the recipients’ e-mail client.

This completes the preparations for submitting the FSCA report in Swedish MPA’s e-service.

Field safety notice (FSN)

A field safety notice (FSN) shall be sent to all concerned parties (user, distributors, and importers) to inform the users of the concerned devices of the measures to be taken.

The FSN shall clearly state

• information to identify the concerned devices and manufacturer. Whenever possible, use UDI and SRN for identification. If UDI and SRN is not available, use the most unambiguous identifier possible.
• the device malfunction and/or deterioration of safety/performance
• the risks associated with the devices and their use
• actions to be taken by the users
• the measures taken by the manufacturer
• contact points of the manufacturer and its representatives.

A Swedish user of medical devices shall have access to the associated information in Swedish. Therefore, an FSN that concerns devices in use on the Swedish market shall be in available Swedish.
It is suitable to use the commonly agreed template available on the website of the EU Commission.

Swedish MPA have prepared FSN templates in Swedish in Word and PDF formats. The Word template is recommended as it is easier to use and mirrors the template in English. However, the PDF version is better adapted for accessibility – if you foresee that users with screen readers need to access the FSN, please use the PDF version.

FSCA template – nationella medicinska informationssystem (NMI)

FSCA reports and FSN concerning nationella medicinska informationssystem (NMI) shall be submitted in the same manner as medical devices. However, a separate template shall be used for FSCA reports. At this time, it is only available in Swedish.

The template for Field safety notices (FSN) for medical devices shall also be used for nationella medicinska informationssystem (NMI).

The FSCA report and FSN can be saved in either Word or PDF format.

Submission with e-service

Until Eudamed is fully functional and mandatory to use, you shall submit FSCA reports and FSN to the Swedish Medical Products Agency (Swedish MPA, Läkemedelsverket) and other concerned competent authorities according to the above. The Swedish MPA uses an e-service to accept submission.

Use the specified templates to prepare FSCA reports and FSN. FSCA reports shall be submitted without undue delay, but before measures are taken. In cases of utmost urgency, the manufacturer may initiate measures before the FSCA report is submitted.

The manufacturer shall submit FSCA reports together with the FSN to the Swedish MPA with an e-service. The documents that are appropriate for the product type (medical devices or NMI) shall be uploaded in the e-service. Before uploading, please make sure that the documents are properly completed and saved.

FSCA reports regarding medical devices that have used the template ”Report Form Field Safety Corrective Action” shall be uploaded both as PDF and XML format. FSCA reports regarding NMI may be be uploaded in either Word or PDF format.

FSCA reports shall always be accompanied by FSN. Therefore, prepare FSCA reports and FSN simultaneously. FSN shall be available in the languages required by the national competent authorities for all the market where the concerned devices have been made available. FSN shall be submitted as attachments to the FSCA report in the e-service, as well as other document that may be relevant to the FSCA report.

Guidance document