Clinical trials

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

Until EUDAMED is operational, the exchange of information in Liechtenstein will take place via email to medical.devices@llv.li, in particular regarding:

- Application for clinical investigations (see below for further details)

- Notification of substantial modifications according to Art. 75 MDR

- Notification of non-substantial monifications according to Art. 70 para. 2 MDR

- Information requirements at the end or in the event of a temporary halt or early termination according to Art. 77 MDR

- Reporting of serious adverse events (SAEs) and device deficiencies according to Art. 80 MDR and according to MDCG 2020-10/1 and MDCG 2020-10/2

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

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

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

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

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

Clinical investigations according to Art. 74 para. 1 MDR

Clinical investigations according to Art. 74 para. 1 MDR may only be started after they have been approved by the Cantonal Ethics Committee Zurich and reported to the Office of Public Health.

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

The notification obligation to the Office of Public Health must be fulfilled at least 30 days before the start of the investigation (electronic submission of the notification form (MDCG 2021-8) to medical.devices@llv.li).

Other clinical investigation according to Art. 82 MDR

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

Further information

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

- Cantonal Ethics Committee Zurich

- European Commission

In particular, the relevant provisions of the following legal acts apply.

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

Clinical investigations of medical devices fall into category C if the medical device is CE-marked but is not used according to the CE-marked instructions for use (subcategory C1), is not yet CE-marked (C2), or its placing on the market, putting into service or use is prohibited in Switzerland/Liechtenstein (C3). These "pre-market" investigations require authorisation from the Office of Public Health and the Cantonal Ethics Committee Zurich.

The other medical device investigations only require authorisation from the Cantonal Ethics Committee Zurich (category A clinical trials) and do not need to be submitted to the Office of Public Health.

Category C clinical investigations: application for authorisation

The authorisation process is described in the fact sheet BW600_00_015e_MB . Applications for authorisation of a clinical investigation must be submitted on the same day to the Cantonal Ethics Committee Zurich and to the Office of Public Health.

Information on the ethical review as well as the corresponding authorisation procedure can be found on the website of the Cantonal Ethics Committee Zurich.

The Office of Public Health uses Swissmedic's application and notification forms. These are available for download 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 structure of the documents in the specified folder structure (dispatch by e-mail using a zip file).

Submissions during clinical investigations

Sponsors must send spontaneously and without solicitation information to the Office of Public Health and the ethics committee. The fact sheet BW600_00_015e_MB describes duties of the sponsor in regard to the Office of Public Health.

Further information

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

- Cantonal Ethics Committee Zurich

- Swissmedic: Clinical trials of medical devices