Clinical Evaluation: How EU MDR Annex XIV Applies in Switzerland

This article is issue 27 of Volume 3, Registration Dossiers and Technical Requirements, of the 50-article series on medical device registration in Switzerland. Together with the other nine issues in this volume it forms a complete deliverable on this topic; the publication timestamp, issue number, title and unique URL are shown in the table below.

1. Key takeaways

Switzerland has no clinical evaluation provisions of its own; the clinical evaluation is compiled according to EU MDR Annex XIV, in the same way the GSPR is incorporated — MedDO turns the EU requirements into Swiss obligations by reference. What really needs separate handling is closing the loop: MedDO Art. 66(2) provides that periodic summary reports, trend reports and event analyses follow EU MDR Art. 27(5) and Art. 87–89. This means the PMCF conclusions in the clinical evaluation and the trend data on the vigilance side belong to one and the same evidence chain: both sides must use the same data definitions, otherwise Swissmedic’s verification will surface the contradiction of a clinical evaluation claiming safety while the trend reports show anomalies.

2. Legal basis

3. Expert insights

1. The benefits and blind spots of incorporation by reference arrive together. Because MedDO contains no clinical evaluation provisions of its own, the EU clinical evaluation report (CER) can be reused wholesale, with no separate Swiss version. The blind spot: Switzerland is a third country to the EU, and Chapter IV of the MRA has not been updated by the EU since May 2021, so clinical data held in Switzerland and EU-side data are not shared. If the CER relies on clinical investigations or PMCF studies conducted in Switzerland, those data do not appear in the EU system; conversely, post-market data on the EU side reach the Swiss side only when the CH-REP proactively submits trend reports covering inside and outside Switzerland under Art. 66(2bis). The geographic boundary of the data on both sides must be stated in the CER.

2. The equivalence route carries an extra layer of uncertainty in Switzerland. Under EU MDR Annex XIV, data from equivalent devices may support the clinical evidence, but the equivalence claim depends on demonstrating the technical, biological and clinical characteristics of the equivalent device and on having access to its documentation. In the Swiss setting one more layer is added: if the equivalent device’s compliance status rests on a legacy certificate (the transitional arrangement of MedDO Art. 101), its clinical evidence may be grounded in data from the MDD/AIMDD era, whose quality lags today’s standards. The transition periods under MedDO run to 31 December 2027 for high-risk devices and 31 December 2028 for medium- and low-risk devices, with both ordinances having abolished the sell-off period — which means that after the transitions end, CERs resting on legacy evidence will face concentrated update pressure.

3. PMCF and vigilance trends must share the same source, or they will undercut each other. Art. 66(2) points trend reports and event analyses to EU MDR Art. 87–89, and Art. 66(2bis) makes the CH-REP responsible for submitting trend reports for inside and outside Switzerland. Together these impose a practical requirement: the PMCF conclusions in the CER and the trend analysis on the vigilance side must be based on the same data set and the same statistical definitions. The common failure is two departments maintaining the two sides on different update cycles, producing inconsistent conclusions. Once such an inconsistency appears in the follow-up analysis of a serious incident report, it will be pursued directly, and correcting it afterwards costs far more than aligning the pipelines beforehand.

4. Practical recommendations

1. Compile the CER according to EU MDR Annex XIV and include a dedicated section on Swiss applicability, stating the geographic boundary of the data sources.
2. Unify the definitions used for PMCF data and vigilance trend data, align the update cycles of both sides, and appoint one person to maintain them.
3. Where equivalent device data are used, verify in parallel whether the equivalent device’s compliance status falls within the MedDO Art. 101 transition, and plan the evidence update for when the transition expires.
4. Run clinical investigations conducted in Switzerland through the ClinO-MD (SR 810.306) approval route; do not reuse the EU clinical trial notification process.
5. Bring CER update triggers into the change management process: design changes, changes of intended use and vigilance signals reaching thresholds all trigger an update.

5. Verification checklist

• □ The CER follows the structure of EU MDR Annex XIV and contains the Swiss applicability section and the geographic boundary of data sources
• □ PMCF data and vigilance trend data use unified definitions and a single responsible person
• □ Every equivalence claim records the equivalent device’s compliance status and the access to its documentation
• □ An evidence update plan has been assessed for legacy-certificate devices after 31 December 2027 / 31 December 2028
• □ Clinical investigations in Switzerland have been filed through the ClinO-MD (SR 810.306) route
• □ CER update triggers are integrated into the change management process

Legal information verified as of 29 October 2026.

GRZAN provides registration documentation and conformity file support for the Swiss market: CER structuring under EU MDR Annex XIV with Swiss applicability sections, PMCF and vigilance data alignment, equivalence assessments and ClinO-MD filing guidance. Our clinical writing team keeps your evidence chain consistent on both sides of the border. For assistance, contact GRZAN at info@grzanglobal.com.