Explore the IVD requirements currently available for Lithuania, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What expires, what is retained periodically, and when must renewal start?
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.
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.
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).
It is prohibited to place medical devices on the market during the period of suspension of their registration.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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).
Which clinical or IVD performance evidence or study is required and accepted?
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.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
Which evidence, local deltas, formats, and signatures are required?
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
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
Which establishment licences, importer permissions, and distribution controls apply?
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.
Which label and IFU elements, languages, symbols, and translation controls apply?
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).
Which current law, regulation, guidance, and transition provisions apply?
The device chapter of HSL I-552 was amended by Law XIII-2947 (effective 2021-05-26, TAR 2020-11067), Law XIV-1059 (effective 2022-05-26, TAR 2022-09668), Law XIV-2745 (effective 2024-06-21, TAR 2024-11248), and Law XIV-2746 (effective 2024-06-21, TAR 2024-11251).
Dates read from the official LRS portal amendment listing (windows-1257 page text).
Law XIII-2947 Art. 14(2): the EUDAMED-era provisions of the amendment package (Arts. 5 and 10 of Law XIII-2754, i.e. the EUDAMED-based registration/notification and duties regime) enter into force on 2022-11-26, or — if EUDAMED was not fully functional on 2021-05-26 — 24 months after the European Commission's notice that EUDAMED fully performs its functions.
Determines whether the transitional registration regime (HSL Art. 59-1 as effective 2020-05-26) or the EUDAMED-based regime governs a given date.
The national regime is set in Articles 59-1 to 59-6 of the Health System Law (Sveikatos sistemos įstatymas) No. I-552, inserted by Law No. XIII-2754 of 2019-12-20; Article 59-1 governs placing on the market and distribution of devices meeting Regulation (EU) 2017/745 (or the national IVD technical regulation, later aligned to Regulation (EU) 2017/746).
Effective from 2020-05-26
No separate 'Medicinos prietaisų įstatymas' exists; devices are regulated inside the Health System Law I-552. Law XIII-2754's own entry-into-force article (verbatim): 'Šis įstatymas, išskyrus 5, 10 straipsnius ir šio straipsnio 3 dalį, įsigalioja 2020 m. gegužės 26 d.' — i.e. the transitional regime (Arts. 5, 10 excluded) effective 2020-05-26, the EUDAMED-era articles later (see legalbasis.eudamed-dependent-effectiveness).
Which current form, portal, account, and submission package must be used?
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).
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.
Which recall, FSCA, notice, and authority-coordination duties apply?
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
Which registration, notification, listing, reliance, or conformity route applies?
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.
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)
Remotely, by electronic means through the contact centre, or applying directly, in the manner set by the Minister of Health or the authorised institution
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.
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.
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.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
geo:ltu
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
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.
Regulatory reference
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.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
lithuania
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
What review, validation, and applicant stop-clock rules apply?
The 20-working-day registration decision term excludes the period(s) during which deficiencies established under HSL Art. 59-1(7) are being remedied.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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).
Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?
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)).
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
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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).
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.
Which UDI, device listing, database, and traceability duties apply?
VASPVT submits data to the European medical devices database EUDAMED under Regulation (EU) 2017/745 and the IVD regulation.
Healthcare institutions must submit data on discontinuation of use of non-implantable and IVD devices to VASPVT, using the prescribed form, no later than 60 calendar days from the day of discontinuation of use.
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.
What is reportable, by whom, where, in what format, and by what deadline?
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.
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).
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Lithuania
lithuania
LT
🇱🇹
State Health Care Accreditation Service under the Ministry of Health
VASPVT
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
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)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by VASPVT. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to VASPVT including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
VASPVT reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. VASPVT may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, VASPVT issues Lithuania market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
lithuania
Lithuania
LT
VASPVT
38
38
EUR
Yes
38
38
EUR
Yes
device-registration
Registration of a device placed on the Lithuanian market
EUR
38
EUR 38
Per device
Item 4.60¹. Flat duty: the schedule sets no class-dependent amount.
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
registration-data-change
Registration of changed data about a device already placed on the market
EUR
18
EUR 18
Per change
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
technical-inspection-certificate
Certificate authorising a person to perform device technical-condition inspections
EUR
145
EUR 145
Per certificate
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
free-sale-certificate
Free-sale certificate for medical devices
EUR
32
EUR 32
Per certificate
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
clinical-investigation-authorisation
Authorisation of a clinical investigation with a device or of a performance study
EUR
1407
EUR 1,407
Per authorisation
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
clinical-investigation-substantial-modification
Authorisation of substantial modifications to a clinical investigation or performance study
EUR
998
EUR 998
Per modification
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
notified-body-designation-assessment
Assessment of a body applying to be designated a medical-device notified body
EUR
3502
EUR 3,502
Per assessment
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
notified-body-scope-extension-assessment
Assessment of a notified body applying to extend its scope
EUR
1737
EUR 1,737
Per assessment
exact-current
official-verified
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
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
2026-05-01
2026-08-25
2026-08-25
official-verified
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
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.116101/asr
2026-05-01
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
lithuania
Lithuania
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
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.
candidate
rrt-radijo-irenginiu-reglamentas
RRT radio equipment technical regulation
Radio Spectrum
Mandatory If Feature
Radio Equipment
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.
candidate
isakymas-4-459-rohs-market-surveillance
Order 4-459 RoHS market surveillance rules
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
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.
unresolved
gamintoju-savadas-registration-before-supply
Sąvadas registration one working day before first supply
Environmental And Batteries
Mandatory Pre Market
Producer Or Authorised Representative
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.
candidate
savadas-extended-to-article-55
Sąvadas extended to serve as the Article 55 battery register
Environmental And Batteries
Mandatory Pre Market
Battery Producer Or Authorised Representative
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.
unresolved
vaspvt-technical-condition-inspection-permits
VASPVT technical-condition inspection permits
Legal Metrology
Mandatory For Use Site
In Use Device Inspection
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).
candidate
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Lietuvos Respublikos Seimas (e-seimas)
RRT resolution 1V-670 radio equipment technical regulation, consolidated 30 May 2026
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/46ce14f0326711e6a222b0cd86c2adfc/asr
Lietuvos Respublikos Seimas (e-seimas)
Order D1-291 producer and importer registration rules, consolidated — Sąvadas and the pre-supply deadline
https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.344991/asr
e-Seimas
HSL I-552 Art. 59-2 — permits for technical condition inspection of in-use devices
https://e-seimasx.lrs.lt/rs/legalact/TAD/7bcd61c0299811efb121d2fe3a0eff27/
