| Regulatory Authority | Office of Health |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | EUMDR-2017/745 | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Registration Process | Medical Device Registration | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in German Language |
| Clinical Trials Information |
Due to the parallel marketability (see market access), clinical trials with medical devices can be conducted in Liechtenstein either under EEA law or under customs convention law. The sponsor chooses according to which law he wants to conduct the clinical trial. | Click Here |
| Certificate of Free Sale |
The Office of Public Health issues such export certificates for the export of medical devices to third countries to manufacturers or authorised representatives based in Liechtenstein, provided they present the necessary evidence. The certificates are issued exclusively in English. | Click Here |
| Adverse Event Reporting Form | Download |
| Additional Information | Medical devices and in vitro diagnostic medical devices (IVDs) may be placed on the market or put into service in Liechtenstein in accordance with customs convention law if they comply with the Swiss legislation on therapeutic products. |