In particular, the relevant provisions of the following legal acts are to be observed when conducting clinical trials with medical devices.

•  Federal Act on Research involving Human Beings (Human Research Act, HRA)
• Ordinance on Clinical Trials of Medical Devices (ClinO-MD)
• Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices (ClinO)
• Verordnung des Schweizerischen Heilmittelinstituts über seine Gebühren (GebV-Swissmedic)

Pre-market clinical investigations 

Category C (pre-market) clinical investigations are subdivided into the following sub-categories:

• C1: The medical device is CE-marked but is not used in accordance with the CE-marked instructions for use.
• C2: The medical device is not yet CE-marked.
• C3:  The placing on the market, putting into service or use is prohibited in Switzerland.

These "pre-market" investigations must be approved by the Office of Public Health and the Cantonal Ethics Committee of Zurich. Applications for the approval of category C clinical investigations and any subsequent submissions in the approval procedure must be sent on the same day to the Office of Public Health and the Cantonal Ethics Committee of Zurich. The Office of Public Health can issue an approval only if the ethics committee has already approved the same version of the trial documentation.

Trial-related contacts with participants may take place only after the Office of Public Health and the Cantonal Ethics Committee of Zurich have approved the trial on the basis of the current document versions. The approval procedure is described in Information Sheet BW600_00_015e_MB of Swissmedic.

The Office of Public Health uses the application and notification forms of Swissmedic. These can be downloaded from the website of Swissmedic and can be submitted electronically to the Office of Public Health (medical.devices@llv.li). Particular attention should be paid to the organization of the documents in the specified folder structure (sent by e-mail using a zip file).

Post-market clinical investigations 

Other investigations with medical devices only require the approval of the Cantonal Ethics Committee of Zurich (category A clinical investigations) and do not need to be submitted to the Office of Public Health.

Submission during ongoing clinical trials 

During category C clinical trials, sponsors have various approval and reporting obligations towards the Office of Public Health.

Substantial modifications

An application for approval has to be submitted to the Office of Public Health in the following cases:

• Changes that could have a significant impact on the safety, health or rights of the participants
• Changes that could have a significant impact on the robustness or reliability of the data generated by the study
• Change of sponsor

Reporting and notification duties

The following must be reported or notified to the Office of Public Health:

• Serious adverse events that have a causal relationship with the investigational device, the comparator device or the study procedure or where such causal relationship is reasonably possible;
• Device deficiencies that might have led to serious adverse events if appropriate action had not been taken, intervention had not occurred or circumstances had been less fortunate;
• Safety and protective measures;
• Annual report on the safety of participants and on the general progress of the clinical trial;
• Other modifications that do not need to be approved;
• Completion, premature termination or interruption of the trial and final report.

For more information, see the website of Swissmedic and section 7 of Information sheet BW600_00_0015e_MB which can be downloaded from the Website of Swissmedic. The procedures and documents prepared to satisfy the reporting obligations must be described in the trial investigation plan and recorded in the case report forms. These documents are reviewed during the approval procedure of the Office of Public Health.

The Office of Public Health uses the application and notification forms of Swissmedic. These can be downloaded from the website of Swissmedic and can be submitted electronically to the Office of Public Health (medical.devices@llv.li).

For serious incidents during Category A trials (not subject to authorization by the Office of Public Health), the reporting requirements of materiovigilance apply.

In particular, the relevant provisions of Regulation (EU) 2017/745 (MDR) and the EWR-Medizinprodukteverordnung (EWR-MepV) apply.

Until EUDAMED is operational, information will be exchanged in Liechtenstein by e-mail to medical.devices@llv.li  in particular with regard to

• Application for a clinical investigation (see below for further details)
• Notification of substantial modifications according to Art. 75 MDR
• Notification of non-substantial modifications in accordance with Art. 70 para. 2 MDR
• Information obligations at the end of a clinical investigation or in the event of a temporary halt or early termination in accordance with Art. 77 MDR
• Reporting of serious adverse events (SAEs) and product deficiencies in accordance with Art. 80 MDR and in accordance with MDCG 2020-10/1 and MDCG 2020-10/2

Clinical investigations according to Art. 62 and Art. 74 para. 2 MDR

Regardless of the class of the investigational device, a clinical investigation may only be started in Liechtenstein if the Cantonal Ethics Committee of Zurich has approved it and it has been authorized by the Office of Public Health.

Information regarding the ethical review (authorization procedure) can be found on the website of the Cantonal Ethics Committee of Zurich.

The application (MDCG 2021-8) to the Office of Public Health can be submitted electronically (medical.devices@llv.li).

Important: Applications must be submitted to the Cantonal Ethics Committee of Zurich and the Office of Public Health on the same day.

Clinical investigations according to Art. 74 para. 1 MDR

Clinical investigations in accordance with Art. 74 para. 1 MDR may only be started once they have been authorized by the Cantonal Ethics Committee of Zurich and reported to the Office of Public Health.

Information on the ethical review (approval procedure) can be found on the website of the Cantonal Ethics Committee of Zurich.

The obligation to notify the Office of Public Health must be fulfilled no later than 30 days before the start of the clinical investigation (electronic submission of the notification form MDCG 2021-8 to medical.devices@llv.li).

Other clinical investigations according to Art. 82 MDR

Other clinical investigations according to Art. 82 MDR are regulated in Liechtenstein in the same way as clinical investigations conducted to demonstrate the conformity of products. The authorization procedure is therefore based on the "clinical investigations according to Art. 62 and Art. 74 para. 2 MDR".

Further information

Guidance documents and further information can be found on the following websites:

- Cantonal Ethics Committee Zurich

- EU Commission