Vigilance framework: allocation of duties under TPA Art. 59 and MedDO Art. 65-67

This article is the 41st 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

Swiss medical device vigilance is not a case of importing the EU regime wholesale. It is an independent system built from three stacked layers: the statute, the ordinance, and provisions of EU law incorporated by reference. TPA Art. 59 writes the notification duty into the law itself, MedDO Art. 65-67 determine who reports and what must be reported, and the format and deadlines for reporting point directly to EU MDR Art. 27(5) and Art. 87-89. The mistake foreign manufacturers make most often is assuming that completing a submission in EUDAMED also discharges the Swiss obligation. It does not. The recipient of a Swiss vigilance report is Swissmedic, and the triggers are anchored to territory: a serious incident that occurred in Switzerland or a field safety corrective action, an FSCA, taken in Switzerland. Everything else in the system, from the choice of first reporter to the treatment of trend signals, flows from these two anchor points, and a vigilance programme that ignores them will look complete on paper while leaving the Swiss exposure unmanaged.

2. Legal basis

3. Expert insights

1. The first reporter is locked to the party that holds design and risk information. Art. 66(1) places the reporting duty on the manufacturer, or on the assembler of systems or procedure packs who places them on the Swiss market. Importers and distributors carry no independent reporting duty under the vigilance articles of the MedDO. This allocation is a deliberate design choice: only the manufacturer holds the design history, the risk management documentation and the historical baseline of comparable events, and letting that party speak directly to the regulator minimises information loss along the way. The price of that design is visible on the import side. A foreign manufacturer usually lacks a local channel through which Swiss clinical use feedback reaches it quickly, so the ordinance adds Art. 66(2bis), which makes the CH-REP a fallback reporter (discussed in detail in article 43 of this series). The reverse side of the allocation is equally clear: concentrating the duty on the manufacturer means that once its internal information chain breaks, responsibility cannot be shared downstream with importers or distributors.

2. The territorial limitation is offset in the opposite direction by the trend reporting duty. Read alone, Art. 66(1)(a) covers only serious incidents that occurred in Switzerland, and Art. 66(1)(b) covers only FSCA taken in Switzerland. On that narrow view, the Swiss authority would appear blind to events abroad. But Art. 66(2) incorporates EU MDR Art. 88 on trend reporting, and Art. 66(2bis) then requires the CH-REP to submit trend reports covering data both inside and outside Switzerland. The balance the legislator struck is this: individual incidents are assessed by territory, while trend signals are assessed globally. Switzerland declines to duplicate incident reporting that another jurisdiction already handles, but it refuses to give up its own safety net against statistically abnormal patterns. For a foreign manufacturer this means the Swiss vigilance file cannot simply mirror the EU file; the trend analysis must explicitly address worldwide data.

3. Formal requirements are written into the substantive provision, so a format error equals no report at all. Art. 66(5) requires reports to be submitted electronically and in a machine-readable form, and Swissmedic publishes the electronic submission channel and the form to be used, currently MU680_20_008e_WL, in the version of 1 April 2026. This requirement was introduced by the ordinance amendment of 19 May 2021 and has applied since 26 May 2021 (AS 2021 281). Reading it as a procedural hint is dangerous. Machine readability is not a technical preference; it is a precondition for a valid report. A manually transcribed summary, a scanned PDF or a free-text email does not satisfy the provision, however complete the underlying content may be. A submission that fails the format requirement leaves the manufacturer exposed as if it had never reported, and the statutory clock keeps running while the defect is repaired.

4. Practical recommendations

1. Maintain a Swiss vigilance log parallel to the EU process. Anchor every clock to the day of awareness, and flag separately whether the incident occurred in Switzerland and whether the FSCA was taken in Switzerland.
2. Fix the information path from user to the manufacturer vigilance function and then to the CH-REP in the quality system documentation, with internal deadlines that reserve processing time for the CH-REP so the statutory reporting window is not consumed.
3. Connect directly to the electronic submission channel published by Swissmedic and replace manual intermediaries with a system-to-system link, placing the form version under change management. The current form version dates from 1 April 2026.
4. Route IVD products through the parallel provisions of IvDO Art. 58-60. Build a separate SOP and form mapping for them; do not run devices and IVD through the same template.
5. Keep a written justification for every decision that a Swiss report is not triggered, especially territorial and severity judgements, so the reasoning can be evidenced during an inspection.

5. Verification checklist

• □ The vigilance SOP distinguishes the two trigger classes: serious incidents occurring in Switzerland and FSCA taken in Switzerland.
• □ The submission method meets the electronic and machine-readable requirements of Art. 66(5) and uses the form currently published by Swissmedic.
• □ The foreign manufacturer has confirmed the fallback duties of the CH-REP under Art. 66(2bis) and recorded them in the mandate agreement.
• □ A separate provision mapping table exists for IVD products under IvDO Art. 58-60.
• □ The user reporting channel under TPA Art. 59 para. 3 is indicated in the information supplied with the device and points to Swissmedic.
• □ Every not-applicable decision is documented in writing and signed off by a reviewer.

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 maintains Swiss and EU vigilance logs in parallel, coordinates CH-REP fallback duties under Art. 66(2bis), and prepares electronic, machine-readable submissions that satisfy Art. 66(5). For support with your Swiss post-market obligations, contact info@grzanglobal.com.