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Office of Public Health · Europe

Liechtenstein medical device regulatory resources

Every Liechtenstein dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

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

AI medical device classifier

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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 47 source-linked facts →

23 of 25 research dimensions currently covered · 20 official sources · latest verification 2026-09-15

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…
Dual EEA and Swiss customs-union supervision
Liechtenstein operates a dual regime: EEA law (MDR/IVDR via EWR MepV/EWR IvDV) governs the EEA channel, while Swiss therapeutics legislation (HMG, Medizinprodukteverordnung/MepV SR 812.213,…
4 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
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…
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…
4 source-linked facts
Checked 2026-08-25
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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
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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
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D05

Registration pathways

Verified
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…
Notification of health-institution manufactured products
Health institutions manufacturing and using products in house (MDR Art. 5(5)) must declare to the Amt für Gesundheit before putting them into service: their name and address, name and inten…
4 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
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…
3 source-linked facts
Checked 2026-09-15
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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
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D08

Establishment, import & distribution

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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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
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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
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Submission & evidence

D11

Label, IFU & language

Verified
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…
Field safety notice and trial overview in German
The field safety notice per MDR Art. 89(8) and the general overview of the clinical investigation per MDR Annex XV Chapter II No. 3.1.5 must be in German.
6 source-linked facts
Checked 2026-08-25
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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
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D13

Standards, testing & ancillary approvals

Unresolved
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
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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
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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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
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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
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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
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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
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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
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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
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D22

Vigilance & incident reporting

Verified
Dual vigilance channels: Swissmedic and Amt fĂĽr 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…
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…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Scope of Amt fĂĽr 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
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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
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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
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Government fees

Full fee schedule (5 lines) →

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

Fee lineAmountProvenance
Processing of a notification for placing a device on the marketCHF 300Verified
Exceptional authorisation for a non-compliant deviceCHF 1,000Verified
Authorisation of a new clinical investigationCHF 5,000Verified
Notified-body first designation or renewalCHF 15,000Verified
1 more fee lines on the full schedule · 5 of 5 rows source-verified

Registration timeline

Full registration timeline →

Office of Public Health (Office of Public Health) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR (EEA) classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Liechtenstein regulation news →

Newest official Office of Public Health headlines from the daily-refreshed feed — every row links directly to the authority publication.

May 6OOOffice of Public HealthMandatory Use of EUDAMED and swissdamed for Medical DevicesLiechtenstein
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Liechtenstein cybersecurity evidence review

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