Office of Public Health market access

Liechtenstein medical device registration resources

Research Office of Public Health registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Liechtenstein medical device resource.

5 free resources24/25 requirements coveredAug 2026 fees reviewed

Run the classification agent

Everything we track for Liechtenstein

Browse by resource instead →

Medical device regulation news

Follow recent Office of Public Health policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary Amt für Gesundheit risk class with official rule references.

Government registration fees

Review current Office of Public Health application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Liechtenstein requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 46 source-linked facts →

24 of 25 research dimensions currently covered · 18 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: The Amt für Gesundheit (Office of Public Health) is the competent authority of Liechtenstein for implementing Regulation (EU) 2017/745 (MDR) and the national EWR MepV; EWR IvDV Art. 17(1) a…
Tasks of the Amt für Gesundheit (medical devices): The Amt für Gesundheit is tasked in particular with: registration of manufacturers, authorised representatives and importers under MDR Art. 31; issuing exceptional authorisations for non co…

4 source-linked facts

Checked 2026-08-25

Open details →

D02

Legal basis & guidance

Verified

National MDR implementation ordinance: The EWR Medizinprodukteverordnung (EWR MepV, LGBl 2021 Nr. 161, in force 26 May 2021) regulates the placing on the market of medical devices in the EEA in Liechtenstein; its annex incorpora…
National IVDR implementation ordinance: The EWR In vitro Diagnostika Verordnung (EWR IvDV, LGBl 2022 Nr. 143, in force 26 May 2022) regulates the placing on the market of IVDs in the EEA in Liechtenstein per EEA Agreement Annex I…

4 source-linked facts

Checked 2026-08-25

Open details →

D03

Device definition & scope

Verified

Definitions follow MDR/IVDR: Liechtenstein defines device terms by direct reference: the definitions of EEA Agreement Annex II Chapters X and XXX, in particular Regulation (EU) 2017/745 (and Regulation (EU) 2017/746 fo…

1 source-linked fact

Checked 2026-08-25

Open details →

D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme

Checked 2026-08-26

Open details →

D05

Registration pathways

Verified

Market-access route: Medical devices may be placed on the market in Liechtenstein if they comply with EEA Agreement Annex II Chapters X and XXX, in particular Regulation (EU) 2017/745 (CE route); EWR IvDV Art.…
Notification duty for custom-made devices: Anyone making custom made devices (MDR Art. 2(3)) available on the market in Liechtenstein must declare to the Amt für Gesundheit before supply: name and address of the manufacturer and all…

4 source-linked facts

Checked 2026-08-25

Open details →

D06

Reliance & recognition

Verified

EU CE under MDR/IVDR - single market validity: target: geo:lie · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
Swiss authorisations valid across the customs territory: Exceptional authorisations (Ausnahmebewilligungen) for non compliant devices issued by Swissmedic under the Swiss side rules (Art. 22 Abs. 1 MepV, Art. 18 Abs. 1/61 Abs. 3 IvDV) are valid f…

2 source-linked facts

Checked 2026-08-25

Open details →

D07

Economic-operator roles

Verified

No Swiss authorised representative for Liechtenstein manufacturers: Manufacturers established in Liechtenstein do not need to appoint a Swiss authorised representative for the customs union channel (Art. 51 MepV / Art. 44 IvDV); authorised representatives s…

1 source-linked fact

Checked 2026-08-25

Open details →

D08

Establishment, import & distribution

Verified

Controls on devices not eligible for Switzerland: Anyone supplying (for payment or free of charge) medical devices that do not meet the requirements for moving into or placing on the market in Switzerland must draw attention to the prohibi…
Reporting of first import of IVDs not eligible for Switzerland: Whoever first imports into Liechtenstein, or places on the market there, IVDs that do not meet the requirements for moving into or placing on the market in Switzerland must report this to t…

2 source-linked facts

Checked 2026-08-25

Open details →

D09

Dossier requirements

Verified

Language of regulatory documentation: Technical documentation, information and documentation per MDR Art. 10(14), Art. 11(3)(d) and Art. 41, the EU declaration of conformity (MDR Art. 19(1)) and the EU certificate (MDR Art. 56(…

1 source-linked fact

Checked 2026-08-25

Open details →

D10

Official forms & portals

Verified

Official submission surfaces: The national submission surface is the Amt für Gesundheit: health institution product declarations before putting into service (EWR MepV Art. 12; EWR IvDV Art. 14), custom made device decla…

1 source-linked fact

Checked 2026-08-25

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

German labelling and IFU (medical devices): Labelling and instructions for use (product information) per MDR Art. 10(11) must be in German in Liechtenstein; symbols concretised by technical standards may replace verbal statements.
English exception for professional-use devices: Product information may be in English instead of German if: the product is supplied exclusively to professionals or is a custom made or health institution manufactured product; the user is…

6 source-linked facts

Checked 2026-08-25

Open details →

D12

QMS, audit & inspection

Verified

Hospital reporting system and vigilance contact person: Hospitals must operate an internal reporting system for serious incidents within an established quality management system and designate a suitable qualified vigilance contact person with me…
Swissmedic inspections in Liechtenstein: Swissmedic conducts inspections in Liechtenstein at the request of the Amt für Gesundheit (e.g. maintenance, reprocessing and vigilance in hospitals; review of tissue/cell establishments),…

2 source-linked facts

Checked 2026-08-25

Open details →

D13

Standards, testing & ancillary approvals

Verified

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Funkanlagen ordinance applying the RED directly under the EEA Agreement: Wireless / radio

7 maintained overlays

Checked 2026-09-07

Open details →

D14

Fees

Verified

Processing of a notification for placing a device on the market: CHF 300
Exceptional authorisation for a non-compliant device: CHF 1,000

5 maintained fee lines

Checked 2026-08-25

Open details →

D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

Open details →

D16

Approval validity & renewal

Verified

Certificate validity and renewal (Art. 56(2)): EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…

1 source-linked fact

Checked 2026-08-29

Open details →

Lifecycle & post-market

D17

Change control

Verified

30-day change notification for national declarations: Changes to the declared data must be reported to the Amt für Gesundheit within 30 days of the change occurring: for health institution manufactured products (EWR MepV Art. 12(3); EWR IvDV A…

1 source-linked fact

Checked 2026-08-25

Open details →

D18

UDI, listing & traceability

Verified

Hospitals must capture and store IVD UDI: Health institutions (IVDR Art. 2(29)) must capture and store, preferably electronically, the UDI (IVDR Art. 2(15)) of the IVDs they have procured, insofar as those products belong to produc…
Official UDI or listing surface: eeaChannel: EUDAMED (EU level) · nationalDelta: Health institutions in Liechtenstein must capture and store the UDI of procured IVDs (EWR IvDV Art. 12) · customsChannel: Swissmedic registra…

2 source-linked facts

Checked 2026-08-25

Open details →

D19

Clinical investigation & performance

Verified

Clinical investigation authorisation and ethics opinion: A clinical investigation per MDR Art. 2(45) may only start once the ethics commission designated by the Government has delivered a favourable opinion and the Amt für Gesundheit has authoris…
Government-designated ethics commission: The Government designates the ethics commission responsible for clinical trials (Art. 57(4) Swiss HMG) and is empowered to transfer this function to a Swiss cantonal ethics commission by ad…

5 source-linked facts

Checked 2026-08-25

Open details →

D20

Special access & derogation

Verified

Exceptional authorisations for non-compliant products: The Amt für Gesundheit grants exceptional authorisations for the placing on the market and putting into service of non compliant medical devices under MDR Art. 59 (EWR MepV Art. 18(2)(b));…

1 source-linked fact

Checked 2026-08-25

Open details →

D21

Manufacturer PMS

Verified

15-year retention of hospital QMS records: Hospitals must retain records and all documents created within the quality management system for serious incident reporting for at least 15 years (EWR MepV Art. 16(4); EWR IvDV Art. 16(4) m…

1 source-linked fact

Checked 2026-08-25

Open details →

D22

Vigilance & incident reporting

Verified

Professional users must report serious incidents: Professionals who identify a serious incident (MDR Art. 2(65); for IVDs IVDR Art. 2(68)) during application of products within the scope of MDR Art. 1(4) / IVDR Art. 1(2) must report it to…
Dual vigilance channels: Swissmedic and Amt für Gesundheit: For products placed on the market under customs treaty law, Swissmedic is competent for vigilance reports (serious incidents occurring in Switzerland or Liechtenstein, field safety correcti…

2 source-linked facts

Checked 2026-08-25

Open details →

D23

Recall, FSCA & market surveillance

Verified

Scope of Amt für Gesundheit post-market control (customs-treaty channel): Under the HMG the Amt für Gesundheit is responsible for post market control of medical devices in particular in retail and dispensing points, craft manufacture of custom made devices, syste…
Market-surveillance measures apply across the customs territory: Market surveillance measures taken by Swissmedic or the Amt für Gesundheit each apply to the whole customs territory (Switzerland/Liechtenstein); the seat of the addressee determines which…

2 source-linked facts

Checked 2026-08-25

Open details →

D24

Advertising, claims & promotion

Verified

Enforcement against unlawful therapeutic-product advertising: The enforcement authority may seize, impound and destroy unlawful advertising material, prohibit its use and publish that prohibition at the expense of the responsible persons, and may temp…

1 source-linked fact

Checked 2026-08-25

Open details →

D25

Submission communications & appeal

Verified

Appeal route against authority decisions: Appeals against decisions of the Amt für Gesundheit (or the Amt für Lebensmittelkontrolle und Veterinärwesen) may be lodged with the Government within 14 days of notification; appeals again…

1 source-linked fact

Checked 2026-08-25

Open details →

Government fees

Full fee schedule (5 lines) →

Office of Public Health registration fees in CHF · reviewed 2026-08-25

Fee line	Amount	Provenance
Processing of a notification for placing a device on the market	CHF 300	Verified
Exceptional authorisation for a non-compliant device	CHF 1,000	Verified
Authorisation of a new clinical investigation	CHF 5,000	Verified
Notified-body first designation or renewal	CHF 15,000	Verified