Clinical trials

in particular, the relevant provisions of Regulation (EU) 2017/745 (MDR) and the EEA Medical Devices Regulation (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 approval of a clinical trial (see below for further details)

- Notification of major variations according to Art. 75 MDR

- Notification of non-substantial amendments in accordance with Art. 70 para. 2 MDR

- Information obligations at the end or in the event of temporary suspension 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 trials according to Art. 62 and Art. 74 para. 2 MDR

Regardless of the class of the investigational device, a clinical trial 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 (approval procedure) can be found on the website of the Zurich Cantonal Ethics Committee.

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

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

Clinical trials according to Art. 74 para. 1 MDR

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

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

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

Other clinical trials according to Art. 82 MDR

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

Regulations for the conduct of clinical trials with medical devices are governed in particular by the following Swiss legal acts. These are applicable in Liechtenstein via the Customs Treaty.

• Federal Act on Research involving Human Beings (Human Research Act, HRA)
• Ordinance on Clinical Trials with Medical Devices (KlinV-Mep)
• Ordinance on Clinical Trials with the Exception of Clinical Trials with Medical Devices (ClinO)
• Ordinance of the Swiss Agency for Therapeutic Products on its Fees (FeeO-Swissmedic)

Clinical trials with medical devices fall into category C if the medical device is CE-marked but is not used in accordance with the CE-marked instructions for use (subcategory C1), is not yet CE-marked (C2), or has been prohibited from being made available on the market, put into service or used in Switzerland / Liechtenstein (C3). These "pre-market" trials require authorization from the Office of Public Health and the Zurich Cantonal Ethics Committee.

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

Category C clinical trials: Application for authorization / authorization procedure

The authorization procedure is described in leaflet BW600_00_015e_MB. Applications for approval of a clinical trial must be submitted to the Zurich Cantonal Ethics Committee and the Office of Public Health on the same day.

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

The Office of Public Health uses the Swissmedic application and notification forms. These can be downloaded from the Swissmedic website 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).

Reporting obligations during ongoing trials

During the conduct of clinical trials in category C, the sponsor must comply with various authorization and reporting obligations vis-à-vis the Office of Public Health.

An application for authorization must be submitted to the Office of Public Health in the following cases:

• Changes that are likely to have a significant impact on the safety, health or rights of the trial subjects
• or the robustness or reliability of the clinical data obtained during the trial,
• Change of sponsor.

The following reporting obligations must be fulfilled with the Office of Public Health:

• Reporting of serious adverse events (SAEs), incl. possible serious product deficiencies.
• Notification of safety and protective measures.
• An annual safety report must be submitted, which includes a current written report and the list of SAEs including product defects that were taken into account in the report.
• Changes to tests and documents that are not subject to approval.
• Completion, termination or interruption of the trial and final report.

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

The procedures and documents that enable the reporting obligations to be fulfilled must be described in the trial protocol and included in the test forms. These documents are checked by the Office of Public Health during the approval procedure.

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

The reporting obligations to the Zurich Cantonal Ethics Committee must also be observed.

Further information

Information sheets, guidance documents and further information can be found on the following websites:

- Cantonal Ethics Committee Zurich

- Swissmedic: Clinical trials with medical devices