Market access

Manufacturers, authorized representatives and importers must register in theEuropean Database on Medical Devices (EUDAMED) in accordance with Article 31 of Regulation (EU) 2017/745 (MDR) and Article 28 of Regulation (EU) 2017/746 (IVDR). The Office of Public Health will verify the entered data and subsequently provide the economic operator with a single registration number ("SRN")

When is registration obligatory?

According to Article 123(3)(d) MDR and Article 113(3)(f) IVDR, the obligation to register applies from the date corresponding to 6 months after the date of publication of the notice regarding of the full functionality of EUDAMED by the EU Commission in the Official Journal of the European Union. Prior to the full functionality of EUDAMED, registration is therefore optional.

The Office of Public Health will control the data entered by economic operators in EUDAMED until the date of application of Art. 31 MDR, resp. Art. 28 IVDR, in a test phase. Any liability, material or immaterial, which could arise from the registration in EUDAMED or the control of the data by the Office of Public Health, is expressly rejected. 

Further information

Guidance documents as well as further information on the registration of economic operators can be found on the website of the European Commission.

Before medical devices and in vitro diagnostic medical devices (IVDs) are placed on the EEA market, they must be registered in the European Database on Medical Devices (EUDAMED) in accordance with Article 29 of Regulation (EU) 2017/745 (MDR) and Article 26 of Regulation (EU) 2017/746 (IVDR).

In principle, device registration in EUDAMED is only mandatory after EUDAMED is fully operational (Art. 123 (3) (d) MDR as well as Art. 113 (3) (f) IVDR). Until then, the corresponding notification obligations according to the Directives 90/385/EEC, 93/42/EEC and 98/79/EC apply. Manufacturers and authorized representatives based in Liechtenstein must thus notify the Office of Public Health of the placing on the market of the following products:

• Class I medical devices
• Systems and procedure packs
• In vitro diagnostic medical devices

However, registration of devices in EUDAMED is recognized by the Office of Public Health. No additional national notification is required.

Further information

Guidance documents as well as further information on the registration of devices can be found on the website of the European Commission.

Custom-made devices

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 (Art. 13 EWR-MepV).

Notification form custum-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 market in Liechtenstein market under EEA law must be notified to the Office of Public Health at least 28 days before making it available (Art. 16 para. 4 MDR, Art. 16 para. 4 IVDR).

Notification form for repackaged / relabeled products (EEA)

Product list medical devices

Product List IVD

Products manufactured in health institutions

Medical devices and IVDs manufactured and used in health institutions must be reported 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

Notification form for IVD manufactured in health institutions

product-list IVD

A distinction is made between two groups of notifiable products containing devitalised 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:

1. According to Art. 1 Abs. 6 Bst. f MDR: products manufactured from derivatives of tissue or cells of human origin that are not viable or that have been killed off.

2.According to Art. 1 Abs. 10 MDR: 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.

These products must be registered in EUDAMED (see 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:

1. All products made from devitalised human tissue or cells, with the exception of derivatives of such tissue or cells
2. 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 included in Regulation (EU) 2017/745 (MDR). In Liechtenstein, the notification obligations according to the Custom Covention Law are therefore applicable. The notification must be submitted to Swissmedic (see website).

Authorisation requirement

The donation, collection, procurement, import and export, storage and testing of non-viable tissues or cells of human origin or their derivatives must be authorized.

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). These products are subject to notification and authorisation requirements.

In Art. 4 MedDO  and Art. 4 IvDO the different roles of the economic operators involved in the making available of medical devices and IVD are defined. Based on the customs union between Liechtenstein and Switzerland, the following applies in particular:

• Manufacturers based in Liechtenstein do not have to appoint an authorized representative to place their medical devices and IVDs on the market in Switzerland. Conversely, manufacturers based in Switzerland also do not have to appoint an authorized representative in Liechtenstein to place their products on the market in Liechtenstein.
   
• Economic operators based in Liechtenstein can act as Swiss authorized representatives (CH-REP), CH-importers and CH-distributors.

Swissmedic has summarized the obligations of economic operators in a fact sheet (see website).

According to Art. 55 MedDO and Art. 48 IvDO, manufacturers, authorized representatives and importers based in Switzerland or Liechtenstein are subject to registration. Swissmedic is responsible for carrying out this registration and the corresponding issuance of the Swiss Registration Number (CHRN).

Further information can be found on the website of Swissmedic.

According to Art. 17 para. 5 MedDO and Art. 16 para. 5 IvDO, medical devices and IVDs must be registered with Swissmedic. Until the corresponding database is completed (see website), the reporting obligations according to Art. 108 MedDO and Art. 90 para. 1 IvDO apply. Swissmedic is responsible for receiving and processing the notifications.

• Art. 108 MedDO: Class I medical devices according to Regulation (EU) 2017/745 (MDR) and Class I medical devices according to Directive 93/42/EEC that belong to Class Ir, IIa, IIb or III according to MDR. The notification obligation applies to manufacturers based in Switzerland or Liechtenstein prior to placing on the common market of Switzerland and Liechtenstein (customs union). (More information and notification form: Website Swissmedic)
• Art. 90 para. 1 IvDO: Manufacturers based in Switzerland or Liechtenstein are required to notify Swissmedic when they place IVDs on the common market of Switzerland and Liechtenstein (Customs Union) for the first time. (More information and notification form: Website Swissmedic)

Custom-made devices (Art. 19 MedDO)

The notification obligation applies to persons (manufacturers, authorized representatives, importers or distributors) based in Liechtenstein or Switzerland prior to making such devices available on the common market of Switzerland and Liechtenstein (customs union). The notification must be submitted to Swissmedic (see website).

Repackaged or relabelled medical devices (Art. 53 / 54 MedDo)

The notification obligation applies to persons (importers and distributors) based in Liechtenstein or Switzerland prior to placing such devices on the common market of Switzerland and Liechtenstein (customs union). The notification must be submitted to Swissmedic (see website).

Repackaged or relabelled IVD (Art. 46 / 47 IvDO)

The notification obligation applies to persons (importers and distributors) based in Liechtenstein or Switzerland prior to placing such devices on the common market of Switzerland and Liechtenstein (customs union). The notification must be submitted to Swissmedic (see website).

In-house medical devices (Art. 18 MedDo)

Medical devices manufactured and used in health institutions must be notified. The notification obligation applies to health institutions based in Liechtenstein or Switzerland prior to putting such devices into service. The notification must be submitted to Swissmedic (see website).

In-house IVDs (Art. 10 IvDo)

IVDs manufactured and used in health institutions must be notified. The notification obligation applies to health institutions based in Liechtenstein or Switzerland prior to putting such devices into service. The notification must be submitted to Swissmedic (see website).

A distinction is made between two groups of notifiable products containing devitalised 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:

1.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.

2.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.

These products are subject to notification according to Art. 108 para. 1 letter b MedDO in conjunction with Art. 6 para. 3 oMedDO until Art. 17 para. 5 MedDO comes into force. The notification must be submitted to Swissmedic (see website).

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:

1. All products made from devitalised human tissue or cells, with the exception of derivatives of such tissue or cells
2. 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.

The notification must be submitted to Swissmedic (see website).

Authorisation requirement

The donation, collection, procurement, import and export, storage and testing of non-viable tissues or cells of human origin or their derivatives must be authorized.

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). These products are subject to notification and authorisation requirements.