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VASPVT · structured requirements

🇱🇹 Lithuania medical device regulatory data

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

41 facts23 dimensions9 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

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

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Misleading claims prohibition (Art. 7)

advertising.misleading-claims-art-7
Fact-level verified

In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: ascribing functions and properties to the device which the device does not have; creating a false impression regarding treatment or diagnosis; failing to inform the user or patient of a likely risk associated with the use of the device in line with its intended purpose; or suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Approval validity & renewal

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

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Free-sale certificate validity

validity.free-sale-certificate
Fact-level verified

A free-sale certificate is valid for as long as the documents proving the device's conformity with Regulation (EU) 2017/745 or the IVD rules are valid, or is valid indefinitely if the validity period of the conformity documents is not specified; the issue/refusal decision is notified in writing within 20 working days (Art. 59-3(4)).

Free-sale certificates for export are issued by VASPVT under HSL Art. 59-3.

Registration cancellation grounds

validity.registration-cancellation-grounds
Fact-level verified

VASPVT cancels the validity of a device registration where: the registered person requests it; the registered legal person is liquidated or the natural person deceased; or other grounds listed in Art. 59-1(12) apply.

Registration suspension for 90 days

validity.registration-suspension-90d
Fact-level verified

VASPVT suspends the validity of a device registration for a period of 90 days from adoption of the decision, on the grounds listed in Art. 59-1(8) (e.g. the registered person's request, or no confirmation of ongoing market-subject status within 90 days of a supervision query).

Authority & regime

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

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Authority role towards notified bodies

authority.ca-notified-body-oversight
Fact-level verified

VASPVT designates testing laboratories and certification/control bodies wishing to become notified bodies for medical-device conformity assessment, supervises them, extends/renews their scope of activities, and suspends/withdraws their designations.

Authority registration and certificate functions

authority.ca-registration-and-certificates
Fact-level verified

VASPVT registers medical devices placed on the market, issues permits entitling persons to perform technical condition inspection of medical devices, and issues free-sale certificates.

Conditions
  • National registration under HSL Art. 59-1 applies to the categories listed there (custom-made, IVD, Class I, systems/procedure packs).

Competent authority

authority.competent-authority
Fact-level verified

The State Health Care Accreditation Service under the Ministry of Health (Valstybinė akreditavimo sveikatos priežiūros veiklai tarnyba prie Sveikatos apsaugos ministerijos, VASPVT; known as VASPMT before its renaming) is the authority empowered by the Minister of Health to implement the national medical-device regime, acting as the competent authority responsible for implementing Regulation (EU) 2017/745.

Conditions
  • Applies to all medical devices and IVDs placed on the Lithuanian market.

Baseline 'State Health Care Accreditation Agency (VASPVT)' corrected to the official Lithuanian name; the current name 'Valstybinė akreditavimo sveikatos priežiūros veiklai tarnyba prie Sveikatos apsaugos ministerijos' is confirmed in the header of VASPVT order No. T1-1369 (res-lt-vaspmt-order-t1-954). The brief's anchor 'VVT / vvtr.lt' is wrong: vvtr.lt is the Vilnius public-transport site, not the device regulator.

Change control

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

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Notification of changed data and market discontinuation

change.changed-data-and-discontinuation
Fact-level verified

Manufacturers (or authorised representatives, system/pack assemblers-sterilisers) must inform VASPVT of changes to the data registered under HSL Art. 59-1(3) and of discontinuation of placing the registered devices on the market.

A changed-data state levy of EUR 18 is indicated on the VASPVT registration page (see fees.registration-levy, unopened page).

Clinical investigation & performance

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

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Clinical investigation permits issued by VASPVT

clinical.investigation-permit-vaspvt
Fact-level verified

VASPVT issues permits to conduct clinical investigations with a medical device and permits for substantial modifications of a clinical investigation with a medical device.

The permit procedure is set by SAM order No. V-2745 (2020-11-26) 'Leidimų atlikti klinikinį tyrimą su medicinos priemone išdavimo tvarkos aprašas'; the order text on e-tar.lt (Cloudflare-blocked) and its listing on bioetika.lrv.lt (blocked) could not be opened, so the procedure details are unverified here.

Device definition & scope

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

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Definitions aligned to MDR

definition.mdr-aligned-definitions
Fact-level verified

Article 2 of the Health System Law defines device terms by direct reference to Regulation (EU) 2017/745 (e.g. 'incident', 'notified body'), so the MDR/IVDR definitions govern nationally with no divergent national device definition.

Dossier requirements

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

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Conformity documents in Lithuanian on request

dossier.conformity-docs-lithuanian-on-request
Fact-level verified

On request of VASPVT (performing state supervision of medical devices), the manufacturer (or authorised representative, assembler/steriliser of systems and packs) must submit, in the Lithuanian state language, documents proving the devices' conformity with Regulation (EU) 2017/745 or Regulation (EU) 2017/746, together with copies of the technical documentation certified as prescribed by law.

Effective from 2024-06-21

Economic-operator roles

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

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Lithuania-established authorised representative

roles.authorised-representative-lithuania
Fact-level verified

Where a device manufacturer has no establishment in an EEA member state, the data required by HSL Art. 59-1(3) must be submitted by the manufacturer's authorised representative established in the Republic of Lithuania.

Conditions
  • Manufacturers of devices in the national registration categories.
  • Manufacturer without establishment in any EEA member state.

Establishment, import & distribution

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

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Ban on supplying devices outside trade premises

distribution.trade-premises-ban
Fact-level verified

It is prohibited to place medical devices on the market outside trade premises and/or to distribute them to consumers; the ban does not apply to distance-contract sales, vending-machine distribution, and sales in healthcare institutions where the law so permits.

Label, IFU & language

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

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Field safety notices in Lithuanian

label.fsn-lithuanian
Fact-level verified

Manufacturers (or their authorised representatives) must provide users and consumers with field safety notices prepared in the Lithuanian state language, in the manner established by Regulation (EU) 2017/745.

Lithuanian-language information rule (English carve-out)

label.ifu-language-rule
Fact-level verified

Information on the proper use and maintenance of a device, referred to in Regulation (EU) 2017/745 or 2017/746, must be attached in the Lithuanian state language, or in English where the information is intended only for healthcare professionals and the healthcare institution to which the device is supplied consents.

Effective from 2024-06-21

Law XIV-2745 Art. 2(2) sets the same rule for importers/distributors in Art. 59-5(2)(9) (information supplied together with the imported/distributed device).

Manufacturer PMS

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

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Post-market surveillance reporting (Arts. 83-86)

pms.reporting-duties-arts-83-86
Fact-level verified

Manufacturers must implement a post-market surveillance system (Art. 83) and a documented post-market surveillance plan proportionate to the risk class and appropriate to the type of device (Art. 84). Class I devices require a post-market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Official forms & portals

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

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In-use device data forms (email, Word/Excel)

forms.in-use-device-data-email
Fact-level verified

Healthcare institutions submit in-use medical-device data to VASPVT (Akreditavimo tarnyba) by email in MS Word (DOC, DOCX) or MS Excel (XLS, XLSX) format, using the forms annexed to the Order (in-use data form, cessation-of-use form).

Conditions
  • Healthcare institutions using medical devices in Lithuania.

Statutory submission channels

forms.submission-channels
Fact-level verified

Registration documents are submitted to the minister-empowered institution (VASPVT) remotely, by electronic means through the contact centre, or by applying directly; the manner of submission is set by the Minister of Health or the authorised institution.

The national forms published on the VASPVT 'Registravimas' page (Cloudflare-blocked, unopenable 2026-08-25) implement this channel rule.

QMS, audit & inspection

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

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Manufacturer quality management system (Art. 10(9))

qms.manufacturer-qms-art-10-9
Fact-level verified

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Recall, FSCA & market surveillance

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

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Immediate recall duties for non-conforming devices

recall.non-conforming-device-actions
Fact-level verified

On learning that devices do not meet the requirements of Regulation (EU) 2017/745 or 2017/746, the responsible economic operator must immediately stop placing them on the market, recall and/or withdraw them from the market, inform VASPVT, potential users and related market subjects, and take other necessary measures to eliminate the danger.

Effective from 2024-06-21

Registration pathways

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

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14-working-day data submission for Class IIA/IIB/III

registration.class-iia-iib-iii-notification
Fact-level verified

Manufacturers, authorised representatives, importers and distributors placing on the Lithuanian market devices classified under Regulation (EU) 2017/745 as Class IIA, IIB or III, or custom-made active implantable devices, must submit to VASPVT data on their establishment address and on devices placed on the Lithuanian market no later than 14 working days after the date of placing on the market.

Conditions
  • Class IIA, IIB, III and custom-made active implantable devices.
  • Data on custom-made active implantables are not submitted under this paragraph if the device was registered under Art. 59-1(3).

Market-access route or official registration surface

registration.market-access-route
Fact-level verified
Submission Surface

National registration/notification with VASPVT under HSL Art. 59-1: document submission for the registered categories (custom-made, IVD, performance-evaluation, Class I, systems/packs), written decision within 20 working days; for Class IIA/IIB/III and custom-made AIMD actors, data notification within 14 working days of placing on the market; the EUDAMED-based regime applies once Law XIII-2754 Arts. 5/10 take effect (2022-11-26 or 24 months after the Commission's EUDAMED functionality notice)

Submission Channels

Remotely, by electronic means through the contact centre, or applying directly, in the manner set by the Minister of Health or the authorised institution

Caveat

The VASPVT 'Registravimas' page publishing the national forms is Cloudflare-blocked to automated access (2026-08-25) and could not be opened to verify the current forms.

National registration scope (EUDAMED-era regime)

registration.scope-eudamed-era
Fact-level verified

The EUDAMED-era version of HSL Art. 59-1(4) extends the national data-submission list to: Class I devices; systems and/or procedure packs; and systems and/or procedure packs that are sterilised (in addition to custom-made, custom active implantable, IVD and performance-evaluation devices).

Applies from the date the EUDAMED-dependent Arts. 5/10 regime takes effect (2022-11-26 or 24 months after the Commission's EUDAMED functionality notice) — see legalbasis.eudamed-dependent-effectiveness.

National registration scope (transitional regime)

registration.scope-transitional
Fact-level verified

Under the transitional regime of HSL Art. 59-1, market actors must submit to VASPVT data on devices defined and classified in Regulation (EU) 2017/745 or the IVD rules that are: custom-made devices; custom-made active implantable devices; in vitro diagnostic devices; and devices manufactured for performance-evaluation purposes; registration is required before those devices may be placed on the Lithuanian market (Art. 59-1(6)).

Effective from 2020-05-26

Transitional list (4 categories). The EUDAMED-era version of the same article expands the list to 7 categories — see registration.scope-eudamed-era.

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.

Lithuania 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 Lithuania (3 records)

LithuaniaUS 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

LithuaniaEU 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-lithuania
Fact-level verified
Target

geo:ltu

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

National Verification

HSL Art. 59-1(1) permits on the Lithuanian market only devices conforming to Regulation (EU) 2017/745 (or, for IVDs, the technical regulation later replaced by references to Regulation (EU) 2017/746); national law adds only registration/notification, language and vigilance duties — it creates no separate national approval.

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
LithuaniaNMPA

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

lithuania

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.
MDR 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.

Review clocks

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

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Special access & derogation

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

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Ministerial exceptional-use derogation

derogation.minister-exceptional-permit
Fact-level verified

The Minister of Health may, in exceptional cases where no equivalent or alternative devices conforming to Regulation (EU) 2017/745 (or the IVD rules) are available, permit devices to be placed on the Lithuanian market even though the conformity-assessment procedures of those regulations were not applied, where the devices are needed to ensure health protection.

A parallel power for devices in use exists in Art. 59-2(2).

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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National technical-inspection regime for in-use devices

standards.technical-inspection-regime
Fact-level verified

Lithuania maintains a national 'technical condition inspection' regime for in-use devices: a mandatory inspection of the device, including verification of all parameters and safety tests, carried out within the time limits and procedure set by device-usage legal acts and the manufacturer; VASPVT issues the permits entitling persons to perform such inspections (Art. 75(2)(8)).

Tacit non-issuance of inspection permits

standards.technical-inspection-tacit-non-issuance
Fact-level verified

Under HSL Art. 59-2(4-1) (added 2024-06-21), failure to adopt a decision on issuing or refusing the permit entitling a person to perform medical-device technical condition inspection within the time limit set in Art. 59-2(4) is not deemed to be issuance of the permit.

Effective from 2024-06-21

Submission communications & appeal

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

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Appeal route against VASPVT decisions

appeal.administrative-proceedings
Fact-level verified

Medical-device market subjects have the right to appeal decisions of the institution empowered by the Minister of Health (VASPVT) under the procedure established by the Law on Administrative Proceedings of the Republic of Lithuania (Administracinių bylų teisenos įstatymas).

30-day deficiency remedy window

deficiencies.remedy-30-days
Fact-level verified

VASPVT refuses registration where the submitted documents are incomplete (or improperly formalised, or the device non-conforming) and the person fails to remedy the indicated deficiencies within 30 days from receipt of the deficiency notice.

UDI, listing & traceability

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

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In-use device data within 30 days of installation

traceability.in-use-device-data-installation
Fact-level verified

Healthcare institutions must submit in-use (non-implantable and IVD) device data to VASPVT, using the prescribed form, no later than 30 calendar days from the installation day of the device.

Conditions
  • Devices listed in the Order's annex categories (expensive healthcare technologies etc.).

Vigilance & incident reporting

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

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Adverse-event reporting during clinical investigations

vigilance.clinical-investigation-ae
Fact-level verified

Sponsors responsible for organising and implementing clinical investigations must report adverse events occurring during clinical investigations in the procedure established by Regulation (EU) 2017/745 or set by the Minister of Health or VASPVT; other persons appointed by the manufacturer must also report under this item.

Incident reporting duty

vigilance.incident-reporting
Fact-level verified

Manufacturers (or authorised representatives, system/pack assemblers-sterilisers) must report incidents in the procedure established by Regulation (EU) 2017/745 or the IVD regulation, or set by the Minister of Health or the institution empowered by him (VASPVT).

Related structured datasets

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

lithuania:medical-device

Jurisdiction Id

lithuania

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

VVKT

Official Domains
  • vvkt.lt
  • eur-lex.europa.eu
  • europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    HSL I-552 Art. 59-1(4) and (11)

    Url

    https://e-seimasx.lrs.lt/rs/legalact/TAD/d9b17ab0288511ea8f0dfdc2b5879561/

    Reviewed On

    2026-08-25

    Supports

    Lithuania has no national classification scheme; MDR Annex VIII (and IVDR Annex VIII) classes apply directly. The national registration duty is class/category-driven: custom-made, custom active implantable, IVD and performance-evaluation devices plus (EUDAMED-era list) Class I devices, systems/procedure packs and sterilised systems/packs require national registration with VASPVT; Class IIA/IIB/III and custom-AIMD actors owe a 14-working-day data notification.

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 Lithuania registration →
Country

Lithuania

Jurisdiction Id

lithuania

Country Code

LT

Flag

🇱🇹

Regulator

State Health Care Accreditation Service under the Ministry of Health

Regulator Abbrev

VASPVT

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

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 Authorized Representative (for non-EU manufacturers)
  • National Class I/IVD registration: register entry published within 20 working days; deficiencies must be cured within 30 days
  • Class IIa/IIb/III distributors/manufacturers established in Lithuania notify VVKT within 14 working days
  • Free-sale certificate issued within 20 working days
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 VASPVT. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to VASPVT including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    VASPVT 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. VASPVT may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, VASPVT issues Lithuania market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

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

lithuania

Country

Lithuania

Country Code

LT

Authority

VASPVT

Low Risk Local
Min

38

Max

38

Currency

EUR

Per Product

Yes

High Risk Local
Min

38

Max

38

Currency

EUR

Per Product

Yes

Details
  • Id

    device-registration

    Item

    Registration of a device placed on the Lithuanian market

    Currency

    EUR

    Amount Local

    38

    Amount Local Formatted

    EUR 38

    Frequency

    Per device

    Notes

    Item 4.60¹. Flat duty: the schedule sets no class-dependent amount.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    registration-data-change

    Item

    Registration of changed data about a device already placed on the market

    Currency

    EUR

    Amount Local

    18

    Amount Local Formatted

    EUR 18

    Frequency

    Per change

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    technical-inspection-certificate

    Item

    Certificate authorising a person to perform device technical-condition inspections

    Currency

    EUR

    Amount Local

    145

    Amount Local Formatted

    EUR 145

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    free-sale-certificate

    Item

    Free-sale certificate for medical devices

    Currency

    EUR

    Amount Local

    32

    Amount Local Formatted

    EUR 32

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    clinical-investigation-authorisation

    Item

    Authorisation of a clinical investigation with a device or of a performance study

    Currency

    EUR

    Amount Local

    1407

    Amount Local Formatted

    EUR 1,407

    Frequency

    Per authorisation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    clinical-investigation-substantial-modification

    Item

    Authorisation of substantial modifications to a clinical investigation or performance study

    Currency

    EUR

    Amount Local

    998

    Amount Local Formatted

    EUR 998

    Frequency

    Per modification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    notified-body-designation-assessment

    Item

    Assessment of a body applying to be designated a medical-device notified body

    Currency

    EUR

    Amount Local

    3502

    Amount Local Formatted

    EUR 3,502

    Frequency

    Per assessment

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

  • Id

    notified-body-scope-extension-assessment

    Item

    Assessment of a notified body applying to extend its scope

    Currency

    EUR

    Amount Local

    1737

    Amount Local Formatted

    EUR 1,737

    Frequency

    Per assessment

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Source Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Source Effective Date

    2026-05-01

    Verified On

    2026-08-25

Notes
  • Lithuania charges a state duty (valstybės rinkliava) rather than an authority tariff, so the amounts are fixed by Government resolution and paid to the tax inspectorate before the service is provided.
  • The EUR 38 duty covers the national registration VASPVT still operates alongside MDR/IVDR; notified-body conformity assessment is priced by the notified body and is outside this authority-fee table.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Lithuania Government Resolution No. 1458, Konkrečių valstybės rinkliavos dydžių sąrašas, items 4.60¹-4.60⁵⁵ (VASPVT section), consolidated edition in force from 2026-05-01

    Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr

    Effective Date

    2026-05-01

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

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

lithuania

Market

Lithuania

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

    rrt-radijo-irenginiu-reglamentas

    Name

    RRT radio equipment technical regulation

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Point 8 of the radio equipment technical regulation approved by RRT council resolution 1V-670 of 14 June 2016, consolidated to 30 May 2026, allows radio equipment to be supplied to the market only where it meets the regulation, which implements Directive 2014/53/EU; points 82 and 93 cover market surveillance by RRT. There is no Lithuanian type approval. Two features could be mistaken for one: point 10 is the verbatim RED article 7(2) power to add conditions on entry into service or use, and points 73 to 82 create a leidimas procedure that operates only while an internal market emergency mode is activated under Regulation (EU) 2024/2747, as a derogation from CE marking rather than a routine requirement.

    Source Urls
    • https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/46ce14f0326711e6a222b0cd86c2adfc/asr
    Source Binding

    candidate

  • Id

    isakymas-4-459-rohs-market-surveillance

    Name

    Order 4-459 RoHS market surveillance rules

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    Lithuania's principal RoHS market-surveillance instrument is the order of the Minister of Economy 4-459 of 8 October 2008 approving the market surveillance rules on restricting certain hazardous substances in electrical and electronic equipment, amended by orders 4-261 of 2013 and 4-120 of 2016. Lithuania notified thirteen measures for RoHS and the substantive rules are spread across this order and the waste management act, so it should be read as the surveillance instrument rather than a complete transposition. The order text itself was not opened, so no article number or competent authority is given. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.

    Source Binding

    unresolved

  • Id

    gamintoju-savadas-registration-before-supply

    Name

    Sąvadas registration one working day before first supply

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Producer Or Authorised Representative

    Note

    Point 1 of the producer and importer registration rules approved by order of the Minister of Environment D1-291 of 27 May 2009, consolidated to amendment D1-151 of 13 August 2026, governs registration in the producers and importers register for those supplying batteries, electrical and electronic equipment and other listed products to the Lithuanian internal market, and point 5 requires registration no later than one working day before the products are first supplied. The register is operated by the Aplinkos apsaugos agentūra within the GPAIS system. The substantive extended-producer-responsibility articles of the waste management act VIII-787 were not separately opened. 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://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.344991/asr
    Source Binding

    candidate

  • Id

    savadas-extended-to-article-55

    Name

    Sąvadas extended to serve as the Article 55 battery register

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Battery Producer Or Authorised Representative

    Note

    Lithuania did not build a new battery register: the August 2026 amendment to order D1-291 states that it implements Article 54(3)(a) of Regulation (EU) 2023/1542, the competent authority's task of registering producers under Article 55, and the rules name batteries expressly among the products covered by the Sąvadas. The one-working-day pre-supply registration deadline in point 5 therefore applies to battery producers as well. 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 Binding

    unresolved

  • Id

    vaspvt-technical-condition-inspection-permits

    Name

    VASPVT technical-condition inspection permits

    Category

    Legal Metrology

    Status

    Mandatory For Use Site

    Object

    In Use Device Inspection

    Note

    No national conformity-assessment certification exists (CE/IVDR routes apply); the national overlay is in-use: VASPVT issues permits entitling persons to perform the mandatory technical condition inspection of in-use devices (HSL I-552 Art. 59-2(4-1), Art. 75(2)(8), Art. 2(15)); failure to decide within the Art. 59-2(4) time limit is not deemed issuance of the permit (effective 2024-06-21).

    Source Urls
    • https://e-seimasx.lrs.lt/rs/legalact/TAD/7bcd61c0299811efb121d2fe3a0eff27/
    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

    Lietuvos Respublikos Seimas (e-seimas)

    Topic

    RRT resolution 1V-670 radio equipment technical regulation, consolidated 30 May 2026

    Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/46ce14f0326711e6a222b0cd86c2adfc/asr

  • Authority

    Lietuvos Respublikos Seimas (e-seimas)

    Topic

    Order D1-291 producer and importer registration rules, consolidated — Sąvadas and the pre-supply deadline

    Url

    https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.344991/asr

  • Authority

    e-Seimas

    Topic

    HSL I-552 Art. 59-2 — permits for technical condition inspection of in-use devices

    Url

    https://e-seimasx.lrs.lt/rs/legalact/TAD/7bcd61c0299811efb121d2fe3a0eff27/

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