Swissmedic has updated its guidance document “FSCA economic operators”, identified as MU680_21_010.
Version 3.3, valid from 17 September 2026, explains when a Field Safety Corrective Action (FSCA) must be reported to Swissmedic and how manufacturers, system and procedure pack producers, authorised representatives and other economic operators should manage the reporting process.
The latest revision expands the guidance on the anonymisation of private individuals in FSCA documentation and corrects a link relating to Liechtenstein.
What Is a Field Safety Corrective Action?
Swissmedic defines an FSCA as a corrective action taken for technical or medical reasons to prevent or reduce the risk of a serious incident associated with a device.
Possible FSCAs include:
physical recalls;
replacement of devices;
modification of a device;
modification of instructions for use;
communication to users intended to reduce a potential health risk.
Examples of problems that may trigger an FSCA include packaging errors, sterility problems, manufacturing defects, software errors and safety-related findings identified during post-market surveillance.
Field Safety Notices
Where an FSCA is implemented, manufacturers or system and procedure pack producers must communicate the action to affected users through a Field Safety Notice (FSN).
The communication should explain the safety issue and the corrective action that needs to be taken.
Swissmedic stresses that manufacturers remain responsible for ensuring that information reaches affected users and, where appropriate, patients.
Who Is Responsible for Reporting?
Manufacturers and system and procedure pack producers are responsible for reporting FSCAs relating to devices placed on the Swiss market.
Where the manufacturer or producer is not established in Switzerland or Liechtenstein, the authorised representativeassumes the reporting responsibility.
The report itself may be submitted by the manufacturer, the system and procedure pack producer or the authorised representative.
Electronic Submission to Swissmedic
FSCAs must be reported using the official Swissmedic FSCA form.
Swissmedic requires reports to be submitted in an electronic, machine-readable format.
The submission package should include:
the completed FSCA reporting form;
the Field Safety Notice;
the customer list;
other relevant supporting documentation.
Reports may be submitted in one of the official Swiss languages or in English.
Customer Lists and Anonymisation
Version 3.3 introduces additional clarification regarding customer information.
Swissmedic expects the customer list to provide a complete overview of affected end customers.
Where end customers are private individuals, personal information must be anonymised. The guidance gives examples such as using customer initials together with place of residence or preferred language.
This update is particularly relevant for FSCAs involving products supplied directly to patients or consumers.
Reporting Timeline
FSCAs must be reported to Swissmedic without undue delay.
Once a manufacturer or system and procedure pack producer determines that an FSCA is necessary, the action should be implemented and reported within a timeframe proportionate to the associated risk.
Except in urgent situations, a draft FSN should also be submitted to the relevant competent authority for comment.
Prior Review of Field Safety Notices
Where a draft FSN has already been submitted to an EU or EEA competent authority for comment under the applicable legal requirements, Swissmedic states that it does not need to be submitted again for prior review in Switzerland.
However, Swissmedic retains the right to require modifications to the FSCA or communication at any time.
Swissmedic Evaluation of FSCAs
Swissmedic evaluates whether the actions proposed or already implemented by the manufacturer are sufficient to reduce or prevent the identified risk.
The authority also assesses whether:
the implementation timeline is appropriate;
instructions to users are adequate;
the communication reaches all relevant stakeholders;
distributors, healthcare users, associations and other affected parties are appropriately informed.
Swissmedic may request additional investigations or corrective measures where necessary.
Publication of Field Safety Notices
With limited exceptions, Swissmedic publishes FSNs concerning devices on the Swiss market, and applicable devices in Liechtenstein, on its public FSCA platform.
Documents submitted for publication should normally consist of one machine-readable PDF per language.
The publication package should include the FSN itself and, where relevant:
a customer acknowledgement form;
an explanation of how follow-up will be performed;
product or batch lists;
other necessary attachments.
Data Protection in Published FSNs
Manufacturers, system and procedure pack producers and authorised representatives remain responsible for the accuracy, completeness and data protection compliance of published FSN content.
Swissmedic states that particularly sensitive personal data should be removed before publication or anonymised where inclusion is essential.
This reinforces the importance of incorporating privacy review into FSCA communication workflows.
Significant Incident and Authority Coordination
Swissmedic may share information about FSCAs with other Swiss authorities, including cantonal authorities or the Federal Office of Public Health, particularly where public health risks are involved.
In individual cases, confidential information may also be exchanged with foreign authorities where necessary to prevent serious health risks.
Monitoring FSCA Implementation
Swissmedic actively monitors whether FSCAs have been implemented.
The conclusion of an FSCA should be reported to Swissmedic using the applicable reporting form.
Manufacturers are expected to demonstrate that affected customers received the FSN and that corrective actions were implemented for all affected devices.
Three-Reminder Expectation
One of the notable operational requirements concerns customers who do not respond to an FSN.
Swissmedic expects manufacturers to contact or remind non-responsive customers at least three times after the Field Safety Notice has been sent.
Where fewer than three reminders are made, the manufacturer should provide a risk-based justification.
This expectation is particularly relevant for companies designing internal FSCA follow-up procedures and effectiveness checks.
Medical Devices and IVDs
The guidance applies broadly to:
medical devices;
accessories;
systems and procedure packs;
in vitro diagnostic medical devices;
associated IVD accessories.
The document references both the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO), together with applicable MDR and IVDR provisions.
Switzerland and Liechtenstein
The guidance also addresses devices supplied in Liechtenstein under Customs Treaty law.
Swissmedic is responsible for processing FSCAs for devices placed on the Liechtenstein market under this legal framework.
The document notes that different regulatory routes may apply in Liechtenstein because of its relationship with both Switzerland and the EEA.
What Changed in Version 3.3?
According to the change history, version 3.3 includes two main updates:
Section 5.2 was expanded to include information on the anonymisation of private individuals;
the link to the website of the Liechtenstein National Administration was corrected.
These changes build on earlier revisions that introduced additional requirements relating to FSN recipient follow-up and Switzerland–Liechtenstein regulatory arrangements.
Impact on Medical Device and IVD Economic Operators
For manufacturers, authorised representatives, importers, distributors and system and procedure pack producers operating in Switzerland, the updated guidance reinforces several practical FSCA compliance expectations.
Stakeholders should pay particular attention to:
timely FSCA reporting;
use of the Swissmedic reporting form;
machine-readable electronic submissions;
complete customer lists;
anonymisation of private individuals;
preparation and distribution of FSNs;
prior competent-authority review where applicable;
public FSN publication requirements;
effectiveness follow-up;
three-reminder expectations for non-responsive customers;
closure reporting;
coordination with Swissmedic throughout the corrective action.
For medical device and IVD organisations, the key message is that FSCA management extends beyond the initial regulatory notification. Companies should maintain robust processes for communication, documentation, customer follow-up, privacy protection and confirmation that corrective actions have been effectively completed.
