REGULATORY AUTHORITY:Devices are regulated by the EU list of Competent Authorities. in Liechtenstein, the responsible authority is Liechtenstein National Administration
CLASSIFICATION SYSTEM: Medical devices are classified according to the EU Risk-based Classification.
Medical Devices: Class I (low), IIa, IIb, III (High)
IVD Devices: A (Low),B,C,D (high)
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I medical devices that would not require the involvement of a Notified Body and Class A IVD devices, For the other classes, it depends on the contract with the notified body and the type of device.I
SPECIAL REQUIREMENTS:
Audits: A Quality Management System ISO 13485 is required.
Technical Local Tests: There is no need for local tests.
Clinical Evaluation/studies: A Clinical Evaluation Report for all classes of medical devices and a Performance Evaluation report for IVD devices in accordance with the EU regulations and guidelines is required.
LOCAL FEES: Application review fees: As per the contract with the Notified Body or the costs of the relevant Competent authority within the EU for Class I MD/Class A IVD.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
LICENSE TRANSFER: Not applicable.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative located in the EU is required for manufacturers based outside the European Union to place their devices on the EU market.
ADDITIONAL INFORMATION: The CE mark is mandatory for market access in 30 countries, including 27 Member States of the European Union and three non-EU countries that are part of the European Free Trade Association (EFTA).EU Member States that require the CE mark for include the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, The CE mark is also mandatory for products subject to EU directives sold in the following EFTA countries: Iceland, Liechtenstein, Norway.
Registration in the EUDAMED system is required for entities operating in the EU, including manufacturers (both EU and non-EU), authorized representatives, and importers.
As a result of Liechtenstein’s membership in the European Economic Area (EEA) and due to the customs union with Switzerland, Liechtenstein belongs to two economic areas with different legal structures. In the movement of goods, EEA law and customs convention law apply next to each other. Goods can be placed on the market in Liechtenstein as far as this complies with one or the other law.
Whoever makes custom-made devices available on the market in Liechtenstein in accordance with EEA law must notify the Office of Public Health before making them available Repackaged or relabeled products
The intention to make a repackaged or relabeled medical device or in vitro diagnostic medical device (IVD) available on the market in Liechtenstein market under EEA law must be notified to the Office of Public Health at least 28 days before making it available
*Note: Specific requirements for local economic operators such as importers and distributors are not included here and may include both additional entity and device registration requirements.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
