Swissmedic Updates Information Sheet on Clinical Investigations of Medical Devices

Swissmedic has updated its information sheet “Clinical investigations of medical devices”, version 6.4, valid from 10 July 2026.

The document is intended for sponsors of clinical investigations of medical devices, contract research organisations and investigators. It provides guidance on the approval process, sponsor reporting requirements and surveillance of clinical investigations by Swissmedic.

The information sheet applies to medical devices, accessories for medical devices and devices without a medical purpose listed in Annex I of the Swiss Medical Devices Ordinance. It does not cover performance studies of IVDs or clinical trials of medicinal products.

Regulatory Framework

The information sheet is valid under the regulation that came into force on 26 May 2021.

Swissmedic refers to several Swiss legal texts applicable to clinical investigations of medical devices, including the Human Research Act, the Therapeutic Products Act and the Ordinance on Clinical Trials of Medical Devices.

The document also notes that Swiss requirements extensively refer to the European Medical Device Regulation (EU) 2017/745. For selected aspects, the document also refers to the Swiss Ordinance on Clinical Trials in Human Research, the Human Research Act Organisation Ordinance and the Swiss Medical Devices Ordinance.

ISO 14155 and Clinical Investigation Planning

Swissmedic highlights ISO 14155, which describes principles of good clinical practice for clinical investigations of medical devices involving human subjects.

According to the information sheet, sponsors must address compliance with ISO 14155 and disclose any deviations in the clinical investigation plan, the list of standards and the Swissmedic approval application form.

Approval of Clinical Investigations

The document explains the different trial categories and responsible authorities in Switzerland.

Category A clinical investigations are generally post-market investigations where the device is CE-marked and used according to the CE-marked instructions for use. These investigations must be submitted to and approved by the competent cantonal ethics committee only, with no submission to Swissmedic required.

Category C clinical investigations are generally pre-market investigations. These include investigations where the device is used off-label, is not CE-marked, or is prohibited in Switzerland. Category C investigations require approval from both Swissmedic and the cantonal ethics committee, with applications submitted on the same day through the respective portals.

Swissmedic also describes the conditions under which a simplified review may be requested for certain category C1 or C2 investigations involving non-invasive Class I or IIa devices.

Reporting Duties and Surveillance

The information sheet sets out reporting and notification duties during clinical investigations.

For category C investigations, the document addresses:

• modifications and amendments;

• safety and protective measures;

• serious adverse events;

• device deficiencies;

• annual reports;

• completion, interruption or premature termination;

• reporting timelines and applicable Swissmedic forms.

Reportable serious adverse events and device deficiencies with serious adverse event potential must be reported to Swissmedic within 7 days.

Version 6.4 also adds information and a link to IMDRF adverse event terminology in the section on serious adverse events and device deficiencies.

Swissmedic may conduct inspections and may withdraw or suspend an approval, or make continuation of an investigation dependent on additional conditions.

Impact on Medical Device Manufacturers and Sponsors

For medical device manufacturers, sponsors, CROs and investigators conducting clinical investigations in Switzerland, the updated information sheet reinforces the importance of structured regulatory planning and complete documentation.

Manufacturers and sponsors should pay particular attention to:

• correct categorisation of clinical investigations;

• whether Swissmedic approval is required;

• alignment with ISO 14155;

• preparation of the clinical investigation plan;

• applicable standards and GSPR information;

• timely submission to Swissmedic and ethics committees;

• SAE and device deficiency reporting;

• risk mitigation measures;

• quality assurance systems;

• use of IMDRF adverse event terminology;

• requirements for sponsors based outside Switzerland.

For manufacturers developing devices for the Swiss market, the document is particularly relevant where clinical investigations are used to support safety, performance, clinical evidence or regulatory submissions.