Trend reports and PSUR: the CH-REP fallback duty under Art. 66(2bis)

This article is the 43rd 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

MedDO Art. 66(2bis) is a genuine step beyond the EU baseline: once an authorised representative in Switzerland, the CH-REP, is required by law, the serious incident and FSCA reporting duties of Art. 66(1) fall on the representative, and the representative must additionally submit trend reports on data inside and outside Switzerland to Swissmedic, as well as the summary of periodic safety update reports required by EU MDR Art. 89(5). Any arrangement that intends to keep this responsibility on the manufacturer’s side must be agreed in writing in the mandate agreement. A verbal understanding or an exchange of emails does not constitute an effective transfer of the duty. Companies that leave this clause vague discover the true allocation only when Swissmedic asks the representative to account for a trend signal, at which point the representative will look to the manufacturer for the data, and the manufacturer will look to the contract for the escape clause, and often find none.

2. Legal basis

3. Expert insights

1. The fallback duty rests on the CH-REP by default; it is not a free choice for the manufacturer. The word order of Art. 66(2bis) matters. It first provides that where a CH-REP is required, the representative bears the duties of para. 1, and only then provides that a transfer of this duty must be agreed in writing in the mandate agreement. The two possible readings lead to entirely different compliance postures: under the reading that the duty rests on the CH-REP by default, a manufacturer that has made no agreement must rely on the representative to perform; under the reading that it may be freely agreed, the manufacturer could retain the duty. The structure of the provision settles it: a written agreement is the precondition for transfer, so where no agreement exists the duty does not shift and the representative remains responsible by law. The counterpoint is uncomfortable: the representative carries a duty it may lack the technical detail to perform, and in practice the gap can only be bridged by information-rights clauses in the mandate agreement.

2. Trend reporting covers data inside and outside Switzerland, which is an active extension of Swiss oversight. The trend reporting duty of EU MDR Art. 88 already exists, but Art. 66(2bis) expressly requires the CH-REP to submit trend reports covering both domestic and foreign data, bringing worldwide signals into the Swiss regulatory field of view. The judgement behind this design is straightforward: the Swiss market is small, and single-country data are rarely sufficient to identify a statistically abnormal increase, so only a global baseline carries analytical meaning. The cost falls on data access. The representative needs a connection to the manufacturer’s global vigilance database, which raises demands on data availability, language and system permissions, and directly raises the substantive threshold for what a CH-REP service must actually deliver.

3. Combined with the direct-document mechanism of Art. 51(3bis), the representative becomes an operational compliance subject. Art. 51(3bis) allows the manufacturer and the CH-REP to agree that the manufacturer submits technical documentation directly upon Swissmedic’s request, with the representative ensuring submission within 7 days (introduced by the amendment of 19 May 2021, in force 26 May 2021, AS 2021 281). Direct document submission solves the problem of what the authority can see; the trend and summary duties of Art. 66(2bis) solve the problem of what can be explained. Together, they make the CH-REP in Switzerland far more than a nominal contact address: it is a compliance subject carrying substantive ongoing duties. This also explains why Art. 52(1) requires the representative to have permanently and continuously at least one PRRC at its disposal.

4. Practical recommendations

1. Include a dedicated vigilance-responsibility clause in the CH-REP mandate agreement, stating who bears the reporting duties of Art. 66(1). If the manufacturer is to retain them, the written agreement must be explicit and signed by both parties.
2. Agree the information rights at the same time: to perform the trend and summary reporting duties, the CH-REP must have access to the manufacturer’s global vigilance data, periodic safety update reports and event analysis conclusions.
3. Build an annual calendar for the summary reports of EU MDR Art. 89(5), aligned with the PSUR cycle on the EU side, so the two rhythms do not drift apart.
4. Verify that the submission channel meets the electronic, machine-readable requirements of Art. 66(5), and retain submission receipts and timestamps.
5. If the direct-submission mechanism of Art. 51(3bis) is chosen, the mandate agreement must state the 7-day submission commitment and the remedies for breach.

5. Verification checklist

• □ The mandate agreement contains a written clause on the allocation of responsibility under Art. 66(2bis), signed by both parties with the original retained.
• □ The CH-REP has the permissions and processes needed to access vigilance data from inside and outside Switzerland.
• □ The submission cycle for the summary reports of EU MDR Art. 89(5) is captured in the annual compliance calendar.
• □ Trigger thresholds and statistical methods for trend reports are defined in the SOP.
• □ The submission method meets the electronic and machine-readable requirements.
• □ The PRRC arrangement of the CH-REP has been verified under Art. 52(1).

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 drafts Art. 66(2bis) responsibility clauses, secures trend-report data access and maintains the Art. 89(5) summary-report calendar for CH-REP mandates. For support with your Swiss post-market obligations, contact info@grzanglobal.com.