Serious incidents and FSCA: how to apply the 2-day, 10-day and 15-day timelines

This article is the 42nd instalment of Volume 5, Post-market Compliance and Regulatory Developments, of the 50-part series on medical device registration in Switzerland. Together with the remaining nine articles of this volume it forms the complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below.

1. Key takeaways

Switzerland has not invented its own reporting deadlines. Through MedDO Art. 66(2) and Art. 66(4) it incorporates the three deadlines of EU MDR Art. 87: incidents constituting a serious public health threat must be reported immediately and no later than 2 days; incidents leading to death or a serious deterioration in health must be reported immediately and no later than 10 days; all other serious incidents must be reported within 15 days of awareness. FSCA are, under Art. 66(1)(b), likewise immediate reporting matters. The task for a company is therefore not to memorise the numbers but to chain three steps, event classification, starting point and submission channel, into one auditable sequence. If classification criteria are not fixed in advance in the SOP, the shortest deadline will be consumed by internal discussion before a single report line is drafted, and the audit trail will show a gap that no explanation can close.

2. Legal basis

3. Expert insights

1. The classification behind the three deadlines is based on consequence, not on device risk class. Under EU MDR Art. 87, incorporated by MedDO Art. 66(2)(4): an incident constituting a serious public health threat must be reported immediately and no later than 2 days; an incident leading to death or a serious deterioration in health must be reported immediately and no later than 10 days; any other serious incident must be reported within 15 days of awareness. The judgement embedded in this design is deliberate: a minor anomaly on a class III device and a collective failure across a population of class I devices are not comparable threats, and the latter is the more urgent one. The practical counterpoint is that the classification itself takes time, and the 2-day track leaves almost no margin for deliberation. Classification criteria must therefore be moved forward into the SOP, replacing case-by-case debate with a checklist-style determination that any trained vigilance officer can execute within hours.

2. The starting point is awareness, and in the Swiss context awareness may be triggered by the CH-REP. Art. 66(1)(a) requires reporting immediately upon awareness, but for a foreign manufacturer awareness often lags the event by days or even weeks. Art. 66(2bis) assigns the reporting responsibility of para. 1 to the CH-REP, which means the legal clock may already be running from the moment the representative receives feedback from a Swiss user. The trade-off is real: this arrangement shortens the regulatory blind spot, but it turns the efficiency of the manufacturer’s internal information transfer into a compliance risk in its own right. A manufacturer cannot argue that headquarters had not yet confirmed the event; the statutory deadline does not wait for internal confirmation loops to complete.

3. FSCA share the reporting channel with incident reports, but serve a different purpose. Art. 66(1)(b) lists FSCA taken in Switzerland as an independent reporting matter, alongside the serious incidents of Art. 66(1)(a). An FSCA is a corrective action the manufacturer takes on its own initiative, such as a recall, an on-site modification or a usage notice, and the point of reporting it is to keep the regulator synchronised with the scope of the market intervention. An incident report, by contrast, is a passive response to something that has already happened. Both routes use the same electronic, machine-readable submission channel and form under Art. 66(5), namely MU680_20_008e_WL in the version of 1 April 2026. In the company’s logs, however, they must be tracked separately, because only separate statistics can answer the regulator’s follow-up question: how many units have you corrected, and how many remain in use?

4. Practical recommendations

1. Convert the three deadlines into a decision checklist: on receipt of information, first determine whether the incident constitutes a serious public health threat, in which case the 2-day track applies; then whether it led to death or a serious deterioration in health, in which case the 10-day track applies; everything else follows the 15-day track.
2. Agree in the contract the maximum time within which the CH-REP forwards Swiss user feedback to the manufacturer vigilance function, and state explicitly that this transfer does not pause the statutory reporting clock.
3. Submit only through the form and electronic channel published by Swissmedic; never substitute an email body or a scanned document, and keep the form version under change management.
4. Record in the FSCA log the corrective scope, the number of units covered, the customer notification method and the completion rate, kept separate from the incident log but cross-referenced to it.
5. Set early-warning points ahead of the deadline: for events managed on the 15-day track, the internal alert should fire well before expiry, accounting for holidays and time-zone delays.

5. Verification checklist

• □ The SOP records the classification criteria and the designated classifier for the 2-day, 10-day and 15-day tracks.
• □ The definition of awareness covers every information entry point: CH-REP, importer and distributor.
• □ FSCA and serious incidents are logged separately and can be cross-indexed.
• □ Submissions use the electronic, machine-readable channel published by Swissmedic, with receipts retained.
• □ An equivalent process has been established for IVD under IvDO Art. 59.
• □ The reporting channel for users, professional operators, is communicated in the product information.

Legal information verified as of 29 October 2026.

GRZAN supports manufacturers entering or operating in the Swiss market with post-market compliance services, covering vigilance reporting, field safety corrective actions and Swissmedic inspection readiness. Our team maps the 2-day, 10-day and 15-day tracks into auditable SOPs, manages CH-REP handover timing and prepares electronic, machine-readable submissions to Swissmedic. For support with your Swiss post-market obligations, contact info@grzanglobal.com.