Market Access
Parallel marketability
As a result of Liechtenstein's accession to the European Economic Area (EEA) and the customs treaty with Switzerland, Liechtenstein belongs to two economic areas with different legal structures. EEA-Law and the law according to the customs treaty (hereinafter Customs-Treaty-Law) apply in parallel to the movement of goods. Goods can be placed on the market in Liechtenstein if they comply with one or the other law.
The free movement of goods within the EEA applies to exports from Liechtenstein only to products that comply with EEA-Law. Customs-Treaty-Law applies to the movement of goods to Switzerland.
Obligation to provide information and to draw up documentation
In Liechtenstein, medical devices and in vitro diagnostic medical devices (IVD) that do not meet the requirements for being brought into Switzerland or placed on the market in Switzerland are subject to the obligation to provide information and to draw up documentaion:
- Information (Art. 8 EWR-MepV, Art. 9 EWR-IvDV): Anyone who transfers medical devices / IVDs that do not meet the requirements for being brought into Switzerland or placed on the market in Switzerland, whether in return for payment or free of charge, must draw attention to the prohibition of commercial or private circumvention traffic into Switzerland in accordance with Art. 9 of the Gesetz über die Verkehrsfähigkeit von Waren.
- Documentation (Art. 9 EWR-MepV, Art. 10 EWR-IvDV): Anyone who transfers medical devices / IVDs that do not meet the requirements for being brought into Switzerland or placed on the market in Switzerland, whether in return for payment or free of charge, must draw up documentation. Said documentation must be kept for five years in a complete and orderly manner. The documentation shall contain in particular information on
- the name and address of the recipient
- the date of delivery
Obligation to notify the import and placing on the market of in vitro diagnostic medical devices
Anyone importing IVDs that do not meet the requirements for being brought into Switzerland or placed on the market in Switzerland into Liechtenstein or placing them on the market in Liechtenstein for the first time must notify the Office of Public Health (Art. 8 para. 1 EWR-IvDV).
Notification form for the import or placing on the market of IVDs
Customs-Treaty-Law
Medical devices and in vitro diagnostic medical devices (IVD) may be placed on the market or put into service in Liechtenstein in accordance with Customs-Treaty-Law if they comply with the Swiss therapeutic products legislation. The Swiss legal provisions applicable in Liechtenstein are listed in an Official Notice.
The following legal acts must be observed in particular:
- Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA)
- Medical Devices Ordinance (MedDO)
- Ordinance on In Vitro Diagnostic Medical Devices (IvDO)
- 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)
Art. 4 MedDo and Art. 4 IvDO define the various roles of the economic operators involved in the provision of medical devices and IVDs on the common market of Switzerland and Liechtenstein (customs union). Based on the customs treaty between Liechtenstein and Switzerland, the following applies in particular:
- Manufacturers based in Liechtenstein and Switzerland are not required to designate an authorized representative to place their medical devices and IVDs on the common market of Switzerland and Liechtenstein (customs union).
- Economic operators domiciled in Liechtenstein can act as CH-REP (authorized representatives), CH-importers and CH-distributors.
Swissmedic has clearly summarized the obligations of economic operators in an information sheet (see website).
Manufacturers, authorized representatives and importers, as well as manufacturers of systems and procedure packs, based in Switzerland or Liechtenstein must, according to Article 55 MedDo and Article 48 IvDO, register in the swiss database on medical devices (swissdamed).
Swissmedic is responsible for carrying out this registration and issuing the corresponding Swiss single registration number (CHRN).
Further information can be found on the website of Swissmedic.
Manufacturers, persons who assemble systems and procedure packs, and authorised representatives must register their devices, systems and procedure packs or, in the case of authorised representatives, their mandated devices, in the UDI Devices module of the swiss database on medical devices (swissdamed) (Article 17 (5) MedDO and Article 16 (5) IvDO).
Further information can be found on the website of Swissmedic.
Custom-made devices (Art. 19 MedDO)
The notification obligation applies to persons (manufacturers, authorized representatives, importers or distributors) domiciled in Liechtenstein and Switzerland prior to making the device available on the common market of Switzerland and Liechtenstein (customs union). The notification must be made to Swissmedic (see website).
Repackaged or relabeled medical devices (Art. 53 / 54 MedDO)
The notification obligation applies to persons (importers and distributors) based in Liechtenstein and Switzerland prior to placing the device on the common market of Switzerland and Liechtenstein (customs union). The notification must be made to Swissmedic (see website).
Repackaged or relabeled IVDs (Art. 46 / 47 IvDO)
The notification obligation applies to persons (importers and distributors) based in Liechtenstein and Switzerland prior to placing the device on the common market of Switzerland and Liechtenstein (customs union). The notification must be made to Swissmedic (see website).
Medical devices manufactured and used in health institutions (Art. 18 MedDO)
The obligation to notify applies to health institutions in Liechtenstein and Switzerland prior to putting such devices into service. The notification must be made to Swissmedic (see website).
IVDs manufactured and used in health institutions (Art. 10 IvDO)
The obligation to notify applies to health institutions in Liechtenstein and Switzerland prior to putting such devices into service. The notification must be submitted to Swissmedic (see website).
There are two groups of notifiable products that contain devitalized human tissue:
MD-DEVIT products
As of 26 May 2021, the following products must undergo a conformity assessment procedure for medical devices and require CE marking:
- According to Art. 1, para. 3 letter c number 2 MedDO: products manufactured from derivatives of tissue or cells of human origin that are not viable or that have been killed off.
- According to Art. 1 para. 3 letter d MedDO: products which contain non-viable tissue or non-viable cells of human origin, or the derivatives of such tissue or cells, as an integral constituent part at the time the products are placed on the market or put into service and where such tissue, cells or derivatives assume a supporting function in such products.
MEP-DEVIT products must be registered in swissdamed. Further information can be found in the upper section “Registration of devices (CT).
DEVIT-products
DEVIT-products according to Art. 2a para. 2 TPA, have to be notified until a special ordinance is issued in accordance with Art. 103 para. 2 MedDo in combination with Art. 6 para. 3 oMedDO. These include:
- All products made from devitalised human tissue or cells, with the exception of derivatives of such tissue or cells
- Products which contain non-viable tissue or non-viable cells of human origin, or the derivatives of such tissue or cells, as an integral constituent part at the time the products are placed on the market or put into service and where such tissue, cells or derivatives assume a primary function in such products.
There is a general obligation to notify Swissmedic if the product is placed on the common market of Switzerland and Liechtenstein (customs union) (see website).
Authorization requirement
The donation, removal, procurement, import and export, storage and testing of non-viable tissue or non-viable cells of human origin or their derivatives is subject to authorization.
Organs, tissues or cells of human or animal origin and products obtained from them (transplant products) which contain living cells and are intended for transplantation to humans are subject to the Transplantation Act (SR 810.21 Federal Act on the Transplantation of Organs, Tissues and Cells). Notification and authorization requirements also apply to these products.
EEA-Law
Medical devices and in vitro diagnostic medical devices (IVDs) may be placed on the market or put into service in Liechtenstein in accordance with EEA--Law if they comply with the provisions of the following legal acts in particular:
- Regulation (EU) 2017/745 on medical devices (MDR)
- EWR-Medizinprodukteverordnung (EWR-MepV)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- EWR-In-vitro-Diagnostika-Verordnung (EWR-IvDV)
Further decrees applicable in Liechtenstein, in particular the implementing acts in connection with the MDR and IVDR, are listed in the EWR-Register of the EEA Coordination Unit (Annex II - Chapter XXX). The decisions of the EEA Joint Committee can be consulted in the EFTA-Lex.
Guidance documents and further information can be found on the website of the European Commission.
Manufacturers, authorised representatives and importers must register in the Actor registration module (ACT module) of the European Database on Medical Devices (EUDAMED) in accordance with Article 31 MDR and Article 28 IVDR. In addition, the following actors must also register in EUDAMED to be able to perform actions within EUDAMED:
- System or procedure pack producers need to register in the ACT module before placing the system or procedure pack on the market.
- Manufacturers who exclusively place custom-made devices on the market need to register in the ACT module before they can use other EUDAMED modules, e.g. to report a serious incident regarding a custom-made device.
- Manufacturers who exclusively place class III custom-made implantable devices on the market need to register in the ACT module to enable Notified Bodies to register the QMS certificates.
- Sponsors of clinical investigations / performance studies need to register as actor in the ACT module to be able to use the CI/PS module (after being functional), e.g. to submit an application for a clinical investigation / performance study or report a serious adverse event.
The Office of Public Health verifies the data entered via EUDAMED and subsequently issues the actor an Actor ID or a Single Registration Number (SRN).
Further information on the registration of actors can be found on the website of the European Commission.
Before placing a device, other than a custom-made device, on the market, it must be registered in the UDI/Device registration module of the European Database on Medical Devices (EUDAMED) in accordance with Article 29 MDR and Article 26 IVDR. Systems and procedure packs that are not custom-made devices must also be registered in EUDAMED before being placed on the market.
Further information on the registration of devices can be found on website of the European Commission.
Custom-made devices
Anyone who 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 (Art. 13 EWR-MepV).
Notification form for custom-made devices (EEA)
Repackaged or relabeled products
The intention to make a repackaged or relabeled medical device or in vitro diagnostic medical device (IVD) available on the Liechtenstein market in accordance with EEA-Law must be notified to the Office of Public Health at least 28 days before it is made available (Art. 16 para. 4 MDR, Art. 16 para. 4 IVDR).
Notification form for repackaged / relabeled products (EEA)
Products manufactured in health institutions
Medical devices and IVDs manufactured and used in health institutions must be notified to the Office of Public Health before being put into service (Art. 12 EWR- MepV, Art. 14 EWR-IvDV).
Notification form for medical devices manufactured in health institutions (EEA)
Notification form for IVDs manufactured in health institutions (EEA)
There are two groups of notifable products that contain devitalized human tissue:
MD-DEVIT products
As of 26 May 2021, the following products must undergo a conformity assessment procedure for medical devices and require CE marking:
- According to Art. 1 para. 6 let. g MDR: Devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable.
- According to Art. 1 para. 10 MDR: Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device
These devices must be registered in EUDAMED (see upper section "Registration of devices (EEA)").
DEVIT-products
DEVIT-products according to Art. 2a para. 2 TPA, have to be notified until a special ordinance is issued in accordance with Art. 103 para. 2 MedDO in combination with Art. 6 para. 3 oMedDO. These include:
- All products made from devitalised human tissue or cells, with the exception of derivatives of such tissue or cells
- Products which contain non-viable tissue or non-viable cells of human origin, or the derivatives of such tissue or cells, as an integral constituent part at the time the products are placed on the market or put into service and where such tissue, cells or derivatives assume a primary function in such products.
DEVIT-products are not covered by Regulation (EU) 2017/745 (MDR). In Liechtenstein, the reporting obligations under the Customs-Treaty-Law therefore apply. The notification obligation must be fulfilled at Swissmedic (see website).
Authorization requirement
The donation, removal, procurement, import and export, storage and testing of non-viable tissue or non-viable cells of human origin or their derivatives is subject to authorization.
Organs, tissues or cells of human or animal origin and products obtained from them (transplant products) which contain living cells and are intended for transplantation to humans are subject to the Transplantation Act (SR 810.21 Federal Act on the Transplantation of Organs, Tissues and Cells). Notification and authorization requirements also apply to these products.