Market access

Manufacturers, authorized representatives and importers must register in the Europeandatabase for medical devices (EUDAMED) in accordance with Art. 31 of Regulation (EU) 2017/745 (MDR) and Art. 28 of Regulation (EU) 2017/746 (IVDR). The Office of Public Health examines the documents submitted and then provides the economic operator with a unique registration number ("SRN" - Single Registration Number).

When is registration mandatory?

According to Art. 123 para. 3 let. d MDR and Art. 113 para. 3 let. f IVDR, the obligation to register applies from the date corresponding to 6 months after the date of publication of the notification of the functionality of EUDAMED by the EU Commission in the Official Journal of the European Union. Registration is therefore optional before EUDAMED is fully functional.

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

Further information

Guidance documents and further information on the registration of economic operators can be found on the website of the EU Commission.

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

In principle, product registration in EUDAMED is only mandatory once EUDAMED is fully functional (Art. 123 para. 3 let. d MDR and Art. 113 para. 3 let. f IVDR). Until then, the corresponding notification obligations in accordance with Directives 90/385/EEC, 93/42/EEC and 98/79/EC apply. Manufacturers and authorized representatives based in Liechtenstein must therefore notify the Office of Public Health of the placing on the market of the following products:

• Class I medical devices
• Systems and treatment units
• In vitro diagnostic medical devices

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

Further information

Guidance documents and further information on the registration of products can be found on the website of the EU Commission.

Custom-made products

Anyone who makes custom-made products available on the market in Liechtenstein in accordance with EEA law must notify the Office of Public Health before making them available (Art. 13 EEA-MepV).

Notification form for custom-made products (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)

Product list medical devices

IVD product list

Devices manufactured in healthcare facilities

Medical devices and IVDs manufactured and used in healthcare facilities must be notified to the Office of Public Health before being put into service (Art. 12 EEA MedDO, Art. 14 EEA IVDO).

Notification form for medical devices manufactured in healthcare establishments (EEA)

Notification form for IVDs manufactured in healthcare establishments (EEA)

List of IVD products

There are two groups of reportable products that contain devitalized human tissue:

MEP-DEVIT products

From May 26, 2021, the following products must undergo a conformity assessment procedure for medical devices and require a CE marking:

1. According to Art. 1 para. 6 let. f MDR: Devices manufactured from derivatives of tissues or cells of human origin that are non-viable or have been killed.

2. According to Art. 1 para. 10 MDR: devices which, when placed on the market or put into service, incorporate as an integral part non-viable tissues or non-viable cells of human origin or their derivatives which have a supporting function within the device

These devices must be registered in EUDAMED (see "Registration of devices (EEA)").

DEVIT products

DEVIT products in accordance with Art. 2a para. 2 TPA must be registered until a corresponding special ordinance is issued in accordance with Art. 103 para. 2 TPA in conjunction with Art. 6 para. 3 TPA. Art. 6 para. 3 aMepV must be notified. This includes:

1. All products from devitalized human tissue or cells with the exception of their derivatives

2. Devices that, when placed on the market or put into service, contain as an integral part non-viable tissue or non-viable cells of human origin or their derivatives that have a primary function within the device

DEVIT products are not covered by Regulation (EU) 2017/745 (MDR). In Liechtenstein, the reporting obligations under customs contract law therefore apply. The notification obligation must be fulfilled vis-à-vis 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 made from them (transplant products) that 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.

Art. 4 MepV and Art. 4 IvDV define the various roles of the economic operators involved in the provision of medical devices and IVDs. Based on the customs treaty between Liechtenstein and Switzerland, the following applies in particular:

• Manufacturers based in Liechtenstein are not required 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 in order to place their products on the market in Liechtenstein.
  
• Economic operators domiciled in Liechtenstein can act as CH authorized representatives, CH importers and CH distributors.

Swissmedic has clearly summarized the obligations of economic operators in an information sheet (see website).

According to Art. 55 TPLRO and Art. 48 TPLRO, manufacturers, authorized representatives and importers based in Switzerland or Liechtenstein are required to register. Swissmedic is responsible for carrying out this registration and issuing the corresponding Swiss Single Registration Number (CHRN).

Further information can be found on the Swissmedic website.

In accordance with Art. 17 para. 5 of the Swiss Medical Devices Ordinance(MedDO) and Art. 16 para. 5 of the Swiss Ordinance on In Vitro Diagnostic Medical Devices(IVDO), medical devices and IVDs must be registered with Swissmedic. Until the corresponding database has been completed (see website), the reporting obligations under Art. 108 MepV and Art. 90 para. 1 IvDV 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 Swiss/Liechtenstein common market (customs union). (Further information and notification form: Swissmedic website)
• Art. 90 para. 1 IvDO: Manufacturers domiciled in Switzerland or Liechtenstein are obliged to notify Swissmedic when they place IVDs on the Swiss/Liechtenstein common market (customs union) for the first time. (Further information and notification form: Swissmedic website)

Custom-made products (Art. 19 MepV)

The notification obligation applies to persons (manufacturers, authorized representatives, importers or distributors) domiciled in Liechtenstein and Switzerland prior to making available on the common market Switzerland/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 on the Swiss/Liechtenstein common market (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 on the Swiss/Liechtenstein common market (customs union). The notification must be made to Swissmedic (see website).

Medical devices manufactured and used in healthcare institutions (Art. 18 MedDO)

The obligation to notify applies to healthcare facilities in Liechtenstein and Switzerland prior to commissioning. The notification must be made to Swissmedic (see website).

IVDs manufactured and used in healthcare facilities (Art. 10 IvDV)

The obligation to notify applies to healthcare establishments in Liechtenstein and Switzerland prior to commissioning. The notification must be submitted to Swissmedic (see website).

There are two groups of reportable products that contain devitalized human tissue:

MEP-DEVIT products

From May 26, 2021, the following products must undergo a conformity assessment procedure for medical devices and require a CE marking:

1. According to Art. 1 para. 3 let. c point 2 MepV: Devices manufactured from derivatives of tissues or cells of human origin that are non-viable or have been killed.

2. According to Art. 1 para. 3 let. d MedDO: devices which, when placed on the market or put into service, contain as an integral part non-viable tissues or non-viable cells of human origin or their derivatives which have a supporting function within the device

These products are subject to a notification obligation in accordance with Art. 108 para. 1 let. b MedDO in conjunction with Art. 6 para. 3 aMPO. Art. 6 para. 3 aMepV until the entry into force of Art. 17 para. 5 MepV. The obligation to notify must be fulfilled vis-à-vis Swissmedic (further information and notification form: Swissmedic website).

DEVIT products

DEVIT products in accordance with Art. 2a para. 2 TPA must be notified to Swissmedic until a corresponding special ordinance is issued in accordance with Art. 103 para. 2 TPA in conjunction with Art. 6 para. 3 TPO. Art. 6 para. 3 aMepV must be notified. This includes:

1. All products from devitalized human tissue or cells with the exception of their derivatives

2. Devices that, when placed on the market or put into service, contain as an integral part non-viable tissue or non-viable cells of human origin or their derivatives that have a primary function in the context of the device

The obligation to notify Swissmedic must be fulfilled (further information and notification form: Swissmedic 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 made from them (transplant products) that 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.