Pure Global AI
Office of Public Health · structured requirements

🇱🇮 Liechtenstein medical device regulatory data

Explore the medical device requirements currently available for Liechtenstein, organized by topic and linked to official sources.

47 facts22 dimensions7 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Enforcement against unlawful therapeutic-product advertising

advertising.enforcement-measures
Fact-level verified

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 temporarily or permanently prohibit advertising for a specific therapeutic product in cases of serious or repeated violations of the advertising provisions of the therapeutics legislation (which includes medical devices under the HMG/customs-treaty channel).

Conditions
  • Content rules on advertising themselves follow the Swiss Heilmittelgesetzgebung applicable via the customs treaty; MDR Art. 7 governs claims at EU level.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Certificate validity and renewal (Art. 56(2))

validity.certificate-validity-art-56-2
Fact-level verified

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 extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures; any supplement follows the same rules.

Conditions
  • EEA rule incorporated into the EEA Agreement and directly applicable in Liechtenstein from 26 May 2021, with EEA and national adaptations; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Verordnung vom 27. April 2021 über den Verkehr mit Medizinprodukten im Europäischen Wirtschaftsraum (EWR-Medizinprodukteverordnung; EWR-MepV), LGBl 2021 Nr. 161 (LR 947.102.104), Fassung 26.05.2021

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority

authority.competent-authority
Fact-level verified

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) assigns it the same role for Regulation (EU) 2017/746 (IVDR).

Effective from 2021-05-26

EWR-MepV = LGBl 2021 Nr. 161; EWR-IvDV = LGBl 2022 Nr. 143. Baseline value 'Office of Public Health' re-verified against the national law.

Dual EEA and Swiss customs-union supervision

authority.dual-market-supervision
Fact-level verified

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, IvDV SR 812.219) has applied in Liechtenstein under the customs treaty since 1 January 2002. The Amt für Gesundheit and Swissmedic cooperate under the administrative agreement of 27 February 2024 (LGBl 2024 Nr. 74); each authority enforces in its own territory and measures apply across the customs territory.

Conditions
  • Applies to devices and IVDs circulating in the customs territory (Switzerland/Liechtenstein) or used in clinical trials there.

Effective from 2024-02-27

Tasks of the Amt für Gesundheit (medical devices)

authority.tasks-md
Fact-level verified

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-compliant devices under MDR Art. 59; receiving and processing vigilance reports under MDR Arts. 87-90; and market surveillance under MDR Arts. 93-99. EWR-IvDV Art. 17(2) lists the parallel IVD tasks (IVDR Arts. 28, 54, 82-85, 88-94).

Effective from 2021-05-26

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical investigation authorisation and ethics opinion

clinical.authorization-requirement-md
Fact-level verified

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 authorised it; the same applies to MDR Art. 70(7)(a) cases. For MDR Art. 74(1) investigations, the ethics opinion plus information to the Amt für Gesundheit at least 30 days before start is required.

Effective from 2021-05-26

Performance study damage coverage (IVDs)

clinical.insurance-minimums-ivd
Fact-level verified

Compensation for damage to participants in IVD performance studies (IVDR Art. 2(42)) must be secured by insurance or guarantee with minimum coverage of CHF 250,000 per person, CHF 20,000 for property damage and CHF 3 million per study; for interventional studies under IVDR Art. 58(1)(b)/(2) and Art. 70(2), or studies with products whose placing on the market, putting into service or use is prohibited in Liechtenstein, the minimums are CHF 1 million / 50,000 / 10 million. Coverage must include damage up to ten years after study completion.

Effective from 2022-05-26

Clinical investigation damage coverage (medical devices)

clinical.insurance-minimums-md
Fact-level verified

Compensation for damage to trial participants must be secured by insurance or guarantee with minimum coverage of CHF 1 million per person, CHF 50,000 for property damage and CHF 10 million per clinical investigation; for MDR Art. 74(1) investigations the minimums are CHF 250,000 / 20,000 / 3 million. Coverage must include damage occurring up to ten years after completion of the investigation.

Effective from 2021-05-26

Customs-route trial submissions and Zurich ethics commission

clinical.submissions-customs-route
Fact-level verified

For clinical trials under customs-treaty law (KlinV/KlinV-Mep, Art. 54 HMG): submissions (authorisation applications and notifications) go to the Amt für Gesundheit; Swissmedic reviews on request of the Amt für Gesundheit, which grants the authorisation; Swissmedic forms apply. Per government decision, the Zurich ethics commission is the responsible ethics commission in Liechtenstein. Swissmedic conducts pre- and post-market trial inspections in Liechtenstein on behalf of the Amt für Gesundheit.

Effective from 2024-02-27

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Definitions follow MDR/IVDR

definition.references-mdr-definitions
Fact-level verified

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 for IVDs), plus Art. 2 of the Gesetz über die Verkehrsfähigkeit von Waren apply. No separate national definition catalogue exists in the EWR-MepV/EWR-IvDV.

Effective from 2021-05-26

For the customs-union channel the Swiss MepV/IvDV definitions apply in Liechtenstein via the customs treaty (see Verwaltungsvereinbarung, Gegenstand).

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Language of regulatory documentation

dossier.document-language
Fact-level verified

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)) must be drawn up in German or English in Liechtenstein (EWR-MepV Art. 10(4)). EWR-IvDV Art. 11(4) sets the same German-or-English requirement for the corresponding IVDR documents (Art. 10(13), 11(3)(d), 37, 17(1), 51(1) IVDR).

Effective from 2021-05-26

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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No Swiss authorised representative for Liechtenstein manufacturers

economic-operator.no-swiss-ar-required
Fact-level verified

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 seated in Liechtenstein, and manufacturers whose representative is seated in Liechtenstein, submit documentation on request directly to the Amt für Gesundheit.

Effective from 2024-02-27

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Reporting of first import of IVDs not eligible for Switzerland

import.ivd-first-import-reporting
Fact-level verified

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 the Amt für Gesundheit; the Amt für Gesundheit keeps a register of these persons and informs them of their duties to give warnings (Art. 9) and keep records (Art. 10, three-year retention).

Effective from 2022-05-26

Controls on devices not eligible for Switzerland

import.swiss-circumvention-controls-md
Fact-level verified

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 prohibition of commercial or private circumvention trade into Switzerland under Art. 9 of the Gesetz über die Verkehrsfähigkeit von Waren (EWR-MepV Art. 8) and keep records containing the recipient name/address and date of supply for five years.

Conditions
  • Applies to devices legally placed on the EEA market in Liechtenstein that lack Swiss market eligibility.

Effective from 2021-05-26

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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English exception for professional-use devices

label-ifu.english-exception-md
Fact-level verified

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 assured to have the necessary professional and language skills and agrees to English; protection of patients, users and third parties is ensured; and effective, performance-related use is not jeopardised.

Conditions
  • All four conditions of Art. 10(2)(a)-(d) EWR-MepV must be met.

Effective from 2021-05-26

German labelling and IFU (IVDs)

label-ifu.german-default-ivd
Fact-level verified

IVD labelling and instructions for use per IVDR Art. 10(10) must be in German; symbols concretised by technical standards may replace verbal statements. English is possible instead of German under conditions parallel to the device rule (professional-only supply or health-institution products, assured user skills and consent, protection of patients/users/third parties, no risk to effective use); the field safety notice per IVDR Art. 84(8) must be German (EWR-IvDV Art. 11(1)-(3)).

Effective from 2022-05-26

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Official forms & portals

Which current form, portal, account, and submission package must be used?

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Official submission surfaces

submission.official-form-or-portal-surface
Fact-level verified

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 declarations before supply (EWR-MepV Art. 13), IVD first-import reports (EWR-IvDV Art. 8), and clinical investigation applications (EWR-MepV Art. 14). Operator/device registration as such runs through EUDAMED (EU-level) for the EEA channel and Swissmedic for the customs-territory channel. Liechtenstein operates no national device database of its own in the EWR-MepV/EWR-IvDV.

Effective from 2021-05-26

llv.li process pages (medical.devices@llv.li; MDCG 2021-8 application form) exist but returned bot-protection errors on review; requirements cited from the national law.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Hospital reporting system and vigilance contact person

qms.hospital-vigilance-system
Fact-level verified

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 medical or technical training who performs the reporting duty towards the Amt für Gesundheit; the person's details are reported to the authority. EWR-IvDV Art. 16(2)-(3) mirrors this for IVDs.

Effective from 2021-05-26

Swissmedic inspections in Liechtenstein

qms.swissmedic-inspections-in-li
Fact-level verified

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), with legal responsibility lying with the Principality of Liechtenstein; the Amt für Gesundheit issues licences on the basis of Swissmedic review.

Effective from 2024-02-27

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Scope of Amt für Gesundheit post-market control (customs-treaty channel)

market-surveillance.ag-post-market-control-scope
Fact-level verified

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, systems and procedure packs, and maintenance and reprocessing of devices at the applying professionals.

Market-surveillance measures apply across the customs territory

market-surveillance.measures-customs-territory
Fact-level verified

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 authority is competent, the Amt für Gesundheit being an independent enforcement authority. Swissmedic informs it of general rulings issued to protect the population, and the Amt für Gesundheit reports events like the cantons do.

Effective from 2024-02-27

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Notification duty for custom-made devices

registration.custom-made-notification
Fact-level verified

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 manufacturing sites; where applicable name and address of the authorised representative; and the codes needed to identify the production categories per MDR Art. 42(13). Changes must be reported within 30 days; the Amt für Gesundheit may exempt low-risk products from the duty.

Effective from 2021-05-26

Notification of health-institution manufactured products

registration.hospital-products-notification
Fact-level verified

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 intended purpose of the product, and its risk class per MDR Annex VIII. EWR-IvDV Art. 14 contains the identical duty for IVDs (per IVDR Art. 5(5) and Annex VIII). Changes are reportable within 30 days and the Amt für Gesundheit may exempt products by risk.

Effective from 2021-05-26

Market-access route

registration.market-access-route
Fact-level verified

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. 7 states the parallel rule for IVDs under Regulation (EU) 2017/746. On top of the EU route, national notifications to the Amt für Gesundheit apply (custom-made devices, health-institution products, IVD first-import reports).

Effective from 2021-05-26

Swissmedic registration for the customs territory

registration.swissmedic-registration-customs-channel
Fact-level verified

For the Swiss customs-union channel, economic operators with seat in Switzerland or Liechtenstein register with Swissmedic (Art. 55 MepV / Art. 48 IvDV), and product registration for all products placed on the market in the customs territory takes place at Swissmedic (Art. 17 MepV / Art. 16 IvDV / Art. 47 HMG); database information is provided to the Amt für Gesundheit on request.

Effective from 2024-02-27

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Liechtenstein approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Liechtenstein (4 records)

LiechtensteinNMPA

Regulatory reference

NMPA certificate does not replace EU conformity assessment

reliance.china-nmpa-no-recognition-route
Fact-level verified
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 procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

liechtenstein

China Classes In Scope

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

null

Target Decision Retained

null

Conditions
  • Determine the local class independently; NMPA Class III is not an automatic EU class assignment.
  • A local regulatory application/decision is not universal: MDR Article 52(7) and IVDR Article 48(10) permit specified self-declaration routes.
  • Clinical, performance and technical evidence must meet the applicable EU requirements; the certificate alone does not replace them.
  • Special-purpose, investigational, custom-made and derogation regimes require separate assessment.
Verordnung vom 27. April 2021 über den Verkehr mit Medizinprodukten im Europäischen Wirtschaftsraum (EWR-Medizinprodukteverordnung; EWR-MepV), LGBl 2021 Nr. 161 (LR 947.102.104), Fassung 26.05.2021MDR consolidated text, 19 July 2026IVDR consolidated text, 10 January 2025

Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.

LiechtensteinSwissmedic

Regulatory reference

Swiss authorisations valid across the customs territory

reliance.swiss-customs-territory-recognition
Fact-level verified

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 for the whole customs territory (Switzerland/Liechtenstein); Liechtenstein accepts Swissmedic acts for the customs-union channel.

Effective from 2024-02-27

LiechtensteinUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)EUR-Lex Regulation (EU) 2017/745 (MDR)EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

LiechtensteinEU conformity assessment

Prior approval / evidence record

EU CE under MDR/IVDR - single market validity

reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-liechtenstein
Fact-level verified
Target

geo:lie

Source Approval

EU CE under MDR/IVDR

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Product Marketing

Same Device Required

Yes

Local Application Required

No

Target Decision Retained

No

Conditions
  • medical devices and IVDs subject to route-specific scope
  • valid CE conformity route for the device
  • country language, economic-operator, EUDAMED, and national vigilance obligations still apply

Effective from 2021-05-26

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Clinical investigation review clock (Art. 70(7))

review.clinical-investigation-clock-art-70-7
Fact-level verified

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

Conditions
  • EEA rule incorporated into the EEA Agreement and directly applicable in Liechtenstein from 26 May 2021, with EEA and national adaptations; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Verordnung vom 27. April 2021 über den Verkehr mit Medizinprodukten im Europäischen Wirtschaftsraum (EWR-Medizinprodukteverordnung; EWR-MepV), LGBl 2021 Nr. 161 (LR 947.102.104), Fassung 26.05.2021

The fixed statutory clock in the MDR is the clinical-investigation authorisation clock; no statutory review deadline is fixed for notified-body conformity assessment itself.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Exceptional authorisations for non-compliant products

derogation.exception-authorization
Fact-level verified

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)); EWR-IvDV Art. 17(2)(b) assigns it the same power for non-compliant IVDs under IVDR Art. 54. Fixed fee: CHF 1,000 per authorisation. For the customs-union channel, Swissmedic issues exceptional authorisations valid for the whole customs territory.

Effective from 2021-05-26

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Official UDI or listing surface

udi.official-listing-surface
Fact-level verified
Eea Channel

EUDAMED (EU-level)

National Delta

Health institutions in Liechtenstein must capture and store the UDI of procured IVDs (EWR-IvDV Art. 12)

Customs Channel

Swissmedic registration/listing for the customs territory per Verwaltungsvereinbarung Anhang Ziff. 2/5

Effective from 2022-05-26

Baseline value replaced: EUDAMED is EU-level; the verified national delta is the hospital UDI-capture duty for IVDs.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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Dual vigilance channels: Swissmedic and Amt für Gesundheit

vigilance.dual-channel
Fact-level verified

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 corrective actions there, periodic summary reports and trends); the Amt für Gesundheit is competent for vigilance reports in the EEA. Hospital vigilance contact persons report to Swissmedic for the customs channel.

Effective from 2024-02-27

Professional users must report serious incidents

vigilance.professional-duty
Fact-level verified

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 the supplier and to the Amt für Gesundheit; reporting may be done through a professional society; deadlines follow MDR Art. 87 / IVDR Art. 82.

Effective from 2021-05-26

For IVDs the parallel rule is EWR-IvDV Art. 16 Abs. 1 (deadlines per Art. 82 IVDR).

Related structured datasets

Classification systems · 1 record
Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →
Id

liechtenstein:medical-device

Jurisdiction Id

liechtenstein

Domains
  • medical-device
Name

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

Description

National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

Amt für Gesundheit

Official Domains
  • gesundheit.llv.li
  • eur-lex.europa.eu
  • europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Art. 12 Abs. 1 Bst. c EWR-MepV

    Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Reviewed On

    2026-08-25

    Supports

    Liechtenstein applies the EU MDR Annex VIII risk classes (I, Is, Im, Ir, IIa, IIb, III) with no national classification scheme or national upclassification rules; EWR-MepV Art. 12(1)(c) expressly anchors risk class to Annex VIII of Regulation (EU) 2017/745, and Art. 4(1) adopts MDR definitions.

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-08-26

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Liechtenstein registration →
Country

Liechtenstein

Jurisdiction Id

liechtenstein

Country Code

LI

Flag

🇱🇮

Regulator

Office of Public Health

Regulator Abbrev

Office of Public Health

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR (EEA)

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Self-declaration (no notified body)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    9

    Unit

    months

    Notes
    • MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
    • Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Key Requirements
  • EU/EEA Authorized Representative (for non-EEA manufacturers)
  • Liechtenstein applies the EU MDR directly as an EEA member (Medical Devices Ordinance)
  • Clinical investigation: 45-day authorisation (+20 with experts) per MDR Art. 70(6) as applied in the EEA
  • Art. 74(1) PMCF investigations notified at least 30 days before start
Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-08-29

Verification Status

partially-verified

Official Sources
  • Title

    Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)

    Url

    https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

    Effective Date

    2027-02-25

    Accessed Date

    2026-08-29

  • Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-08-25

  • Title

    EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

    Url

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110

    Accessed Date

    2026-08-29

Reviewed On

2026-08-29

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Office of Public Health. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Office of Public Health including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Office of Public Health reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Office of Public Health may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Office of Public Health issues Liechtenstein market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Liechtenstein fees →
Jurisdiction Id

liechtenstein

Country

Liechtenstein

Country Code

LI

Authority

Office of Public Health

Low Risk Local
Min

200

Max

200

Currency

CHF

Per Product

No

High Risk Local
Min

5000

Max

5000

Currency

CHF

Per Product

No

Details
  • Id

    market-placement-notification

    Item

    Processing of a notification for placing a device on the market

    Currency

    CHF

    Amount Local

    300

    Amount Local Formatted

    CHF 300

    Frequency

    Per notification

    Notes

    EWR-MepV Art. 19(2)(a); the same amount applies to IVDs (EWR-IvDV Art. 18(2)).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Source Title

    Liechtenstein EWR-MepV Art. 19: medical-device fees

    Verified On

    2026-08-25

  • Id

    exceptional-authorisation

    Item

    Exceptional authorisation for a non-compliant device

    Currency

    CHF

    Amount Local

    1000

    Amount Local Formatted

    CHF 1,000

    Frequency

    Per authorisation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Source Title

    Liechtenstein EWR-MepV Art. 19: medical-device fees

    Verified On

    2026-08-25

  • Id

    clinical-investigation-authorisation

    Item

    Authorisation of a new clinical investigation

    Currency

    CHF

    Amount Local

    5000

    Amount Local Formatted

    CHF 5,000

    Frequency

    Per investigation

    Notes

    Amendment: CHF 1,000. Performance-study equivalents identical under EWR-IvDV Art. 18(2).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Source Title

    Liechtenstein EWR-MepV Art. 19: medical-device fees

    Verified On

    2026-08-25

  • Id

    notified-body-designation

    Item

    Notified-body first designation or renewal

    Currency

    CHF

    Amount Local

    15000

    Amount Local Formatted

    CHF 15,000

    Frequency

    Per designation

    Notes

    Designation change: CHF 10,000.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Source Title

    Liechtenstein EWR-MepV Art. 19: medical-device fees

    Verified On

    2026-08-25

  • Id

    free-sale-certificate

    Item

    Free-sale certificate

    Currency

    CHF

    Amount Local

    200

    Amount Local Formatted

    CHF 200

    Frequency

    Per certificate

    Notes

    Identical duplicate: CHF 100.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Source Title

    Liechtenstein EWR-MepV Art. 19: medical-device fees

    Verified On

    2026-08-25

Notes
  • All other official acts under the EWR-MepV and EWR-IvDV are charged by time and effort at an hourly rate of CHF 200 (Art. 19(1)(b) EWR-MepV; Art. 18(1)(b) EWR-IvDV).
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Liechtenstein EWR-MepV Art. 19: medical-device fees

    Url

    https://www.gesetze.li/konso/pdf/2021161000?version=1

    Accessed Date

    2026-08-25

  • Title

    Liechtenstein EWR-IvDV Art. 18: IVD fees

    Url

    https://www.gesetze.li/konso/pdf/2022143000?version=2

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Liechtenstein certifications →
Slug

liechtenstein

Market

Liechtenstein

Confidence

high

Schemes
  • Id

    lvd-medical-exclusion-mdr-electrical-safety

    Name

    MDR electrical safety in place of the Low Voltage Directive

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/35/oj
    Source Binding

    candidate

  • Id

    emc-directive-disapplied-by-mdr

    Name

    MDR electromagnetic compatibility in place of the EMC Directive

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/30/oj
    Source Binding

    candidate

  • Id

    funkanlagen-verordnung-eea-direct-application

    Name

    Funkanlagen ordinance applying the RED directly under the EEA Agreement

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Liechtenstein does not re-enact the RED's substantive articles. Article 7 of the ordinance of 19 September 2017 (LGBl. 2017 Nr. 254) allows radio equipment to be placed on the market under the goods marketability act where this accords with EEA Agreement Annex II Chapter XVIII, and article 5 declares the listed acts directly applicable and generally binding, Directive 2014/53/EU having been incorporated by EEA Joint Committee Decision No 89/2016 (LGBl. 2017 Nr. 149). Article 9 gives execution and supervision to the Amt für Kommunikation. There is no Liechtenstein type approval. The customs union with Switzerland creates a genuine dual track: article 3(1) applies Swiss customs-treaty law supplementarily, article 3(2) applies it to movement of radio equipment into Switzerland, and article 8 requires anyone supplying equipment that does not meet Swiss requirements to warn against circumvention traffic into Switzerland.

    Source Binding

    unresolved

  • Id

    chemikalien-vollzug-swiss-law-rohs

    Name

    Substance restrictions reaching Liechtenstein through Swiss chemicals law

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    This is a verified negative rather than a gap: Liechtenstein has no ordinance transposing Directive 2011/65/EU, and the EEA acts listed in article 1(3) of the environmental protection act do not include it. Article 1 of the ordinance of 7 July 2015 on the execution of chemicals legislation (LR 814.801.2) instead implements the Swiss chemicals legislation applicable in Liechtenstein by virtue of the Customs Treaty, and article 3(1) gives execution to the Amt für Umweltschutz while article 3(3) reserves the competence of the Swiss authorities. Substance restrictions on electrical equipment therefore arrive through the Swiss ChemRRV rather than through RoHS; the Swiss annex itself was not opened, so only the applicability mechanism is verified here.

    Source Binding

    unresolved

  • Id

    no-national-weee-producer-register

    Name

    No national WEEE producer register

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Producer Or Authorised Representative

    Note

    Another verified negative. Article 1(3)(n) of the environmental protection act (LR 814.01) acknowledges Directive 2012/19/EU as EEA law implemented by that act, but a full read of the consolidated text found no producer register, no registration duty and no market-placement precondition, and the systematic register for waste law branch 814.6 contains no WEEE ordinance. The waste management ordinance registers only collectors, carriers, dealers and brokers. The government's own Bericht und Antrag 103/2015 confirms that the substantive take-back duties are covered by the Swiss VREG, applicable in Liechtenstein under the Customs Treaty. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2012/19/oj
    Source Binding

    candidate

  • Id

    batteries-regulation-eea-incorporation-unconfirmed

    Name

    Batteries Regulation with EEA incorporation unconfirmed

    Category

    Environmental And Batteries

    Status

    Transition Not Yet Mandatory

    Object

    Battery Producer Or Authorised Representative

    Note

    No Liechtenstein instrument was identified and none should be assumed from EU-member analogy. The consolidated environmental protection act contains no reference to Regulation (EU) 2023/1542 or to the repealed Directive 2006/66/EC, and the systematic register for waste law branch 814.6 shows no batteries ordinance and no producer register. Whether the Regulation has been incorporated into the EEA Agreement could not be confirmed because EFTA's EEA-Lex returned HTTP 403. Since a Regulation binds Liechtenstein only once incorporated and made domestically effective, the position to record today is that no Article 55 register exists there and the incorporation status needs checking against EEA-Lex and the LGBl. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.

    Source Urls
    • https://eur-lex.europa.eu/eli/reg/2023/1542/oj
    Source Binding

    candidate

  • Id

    amt-fuer-gesundheit-ionising-radiation-authorisation

    Name

    Amt für Gesundheit ionising radiation handling authorisation

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Medical X Ray Installation

    Note

    Strahlenschutzgesetz (StSG, LGBl. 2010 Nr. 370) art. 3 makes the Swiss radiation-protection legislation applicable in Liechtenstein in addition to the national act, under the 24 September 2010 Liechtenstein–Switzerland radiation-protection agreement and the customs treaty, so the operative licence is the Swiss-law Bewilligung für den Umgang mit ionisierender Strahlung. The Amt für Gesundheit is the licensing and supervisory authority for medicine, research and teaching, and the Swiss BAG assesses the conditions for granting, transferring, amending and withdrawing the authorisation (arts. 31-34 and 37) and the inspection of authorised undertakings. Setting up and operating a medical X-ray system is therefore licence-liable even though the device itself follows the EEA medical device route.

    Source Urls
    • https://www.gesetze.li/chrono/pdf/2018152000
    Source Binding

    candidate

Official Sources
  • Authority

    EUR-Lex

    Topic

    Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope

    Url

    https://eur-lex.europa.eu/eli/dir/2014/35/oj

  • Authority

    EUR-Lex

    Topic

    EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive

    Url

    https://eur-lex.europa.eu/eli/dir/2014/30/oj

  • Authority

    EUR-Lex

    Topic

    RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates

    Url

    https://eur-lex.europa.eu/eli/dir/2011/65/oj

  • Authority

    EUR-Lex

    Topic

    WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register

    Url

    https://eur-lex.europa.eu/eli/dir/2012/19/oj

  • Authority

    EUR-Lex

    Topic

    Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register

    Url

    https://eur-lex.europa.eu/eli/reg/2023/1542/oj

  • Authority

    Gesetze.li (Liechtensteinisches Landesgesetzblatt)

    Topic

    Verordnung über den Verkehr mit Funkanlagen im EWR (LGBl. 2017 Nr. 254) arts. 3, 5, 7 and 9

    Url

    https://www.gesetze.li/konso/pdf/2017254000

  • Authority

    Gesetze.li (Liechtensteinisches Landesgesetzblatt)

    Topic

    Verordnung über den Vollzug der Chemikaliengesetzgebung (LR 814.801.2) arts. 1 and 3

    Url

    https://www.gesetze.li/konso/pdf/2015188000

  • Authority

    Gesetze.li (Liechtensteinisches Landesgesetzblatt)

    Topic

    Umweltschutzgesetz (LR 814.01) art. 1(3)(n) — no producer register in the consolidated text

    Url

    https://www.gesetze.li/konso/pdf/2008199000

  • Authority

    Regierung des Fürstentums Liechtenstein

    Topic

    Bericht und Antrag Nr. 103/2015 — the Swiss VREG applies in Liechtenstein under the Customs Treaty

    Url

    https://bua.regierung.li/BuA/default.aspx?content=111740026&nr=103&year=2015

  • Authority

    Lilex (Liechtensteinisches Landesgesetzblatt)

    Topic

    Strahlenschutzgesetz 2010 and the supplementary application of Swiss radiation law

    Url

    https://www.gesetze.li/chrono/pdf/2010370000

  • Authority

    Lilex (Liechtensteinisches Landesgesetzblatt)

    Topic

    Liechtenstein–Switzerland radiation protection cooperation — BAG support for Amt für Gesundheit authorisations

    Url

    https://www.gesetze.li/chrono/pdf/2018152000

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