Pure Global AI
JAZMP · structured requirements

🇸🇮 Slovenia medical device regulatory data

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

42 facts23 dimensions9 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

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

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Gifts and samples restrictions

advertising.gifts-samples-restrictions
Fact-level verified

When advertising to the professional public it is prohibited to give, offer or promise gifts, financial benefits or material advantages unless of low value (not exceeding the thresholds set for public officials); samples to the general public only in smallest packaging, marked as samples, with records kept; recipients of professional samples may not sell them.

Conditions
  • Fines: EUR 800-4,000 for legal persons (Art. 36(1) points 17-18).

Effective from 2025-06-19

Advertising restricted to professional public

advertising.professional-public-only
Fact-level verified

Advertising of devices is prohibited as defined by Art. 7 MDR and Art. 7 IVDR (misleading claims); devices intended for use only within healthcare activity may be advertised only to the professional public (health workers as defined by the healthcare activity law); mere display of devices listed in Art. 21(3) MDR / Art. 19(3) IVDR remains permitted.

Conditions
  • Fine for breach of Art. 7 via Art. 23(2): EUR 800-4,000 for legal persons.

Effective from 2025-06-19

Approval validity & renewal

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

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Device registration validity

validity.device-registration-no-expiry
Fact-level verified

The interim national device registration under Art. 45 has no validity period and no renewal; the obligation is considered fulfilled once JAZMP announces on its website that the relevant EUDAMED modules (device registration, UDI database, notified-body/certificate system) are available and the corresponding EU requirements are met; operator registrations under Arts. 15-18 instead require annual data confirmation.

Conditions
  • Applies to the interim national register; EUDAMED device-registration transition ends 28 November 2026.

Effective from 2025-06-19

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

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP, Agency for Medicinal Products and Medical Devices) is the competent authority implementing ZMedPri-1, Regulation (EU) 2017/745 and Regulation (EU) 2017/746, and is also responsible for notified bodies; exceptions: the Ministry of Health handles the EU reference laboratory appointment procedure and the Commission of the Republic of Slovenia for Medical Ethics (KME) performs ethics-committee tasks.

Conditions
  • Applies to medical devices and IVDs.
  • JAZMP also appoints members of the MDCG (Art. 103 MDR / Art. 98 IVDR).

Effective from 2025-06-19

ZMedPri-1 = Zakon o medicinskih pripomočkih (UL RS 40/25)

Change control

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

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Change notification deadline

changes.registration-data-8-days
Fact-level verified

Changes to registered data or cessation of activity must be reported to JAZMP within 8 days of the change arising, for distributors (Art. 15(4)), importers/manufacturers/authorised representatives/system-producers (Arts. 41-44) and device registrations including legacy ZMedPri-registered devices (Art. 45).

Effective from 2025-06-19

Clinical investigation & performance

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

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Insurance for investigations

clinical.insurance-sponsor-researcher
Fact-level verified

The sponsor and the researcher must insure their liability for any damage a participant may suffer due to participation, before a clinical investigation or performance study conducted in Slovenia begins; no minimum coverage amounts are prescribed.

Effective from 2025-06-19

Non-insurance is a minor offence (Art. 36(1) point 22)

Clinical investigation assessment with KME

clinical.kme-opinion-30-days
Fact-level verified

JAZMP is the authority approving clinical investigations under Art. 70 MDR; after validating scope (Art. 62) and completeness (Annex XV ch. II), JAZMP and the Medical Ethics Commission (KME) jointly assess applications under Art. 71 MDR; KME delivers its opinion to the sponsor and JAZMP within 30 days of the validation date; point (a) investigations may start immediately after validation, point (b) after JAZMP approval notice, provided KME gave no negative opinion.

Conditions
  • KME reviews Annex XV ch. II sections 1.13, 3.1.3, 3.6.3, 3.12, 3.13, 4.3, 4.4 and 4.5.
  • Application may be in Slovenian or English (Art. 7(3)).

Effective from 2025-06-19

Fee: EUR 2,000 (point (a)) / EUR 4,175 (point (b)) per Tarifa Art. 16

Performance study assessment with KME

clinical.performance-study-kme-opinion
Fact-level verified

For IVDR Art. 58 performance studies, JAZMP verifies scope and completeness (Annex XIV ch. I) and informs the sponsor per Art. 66(1); for point (b) studies JAZMP and KME assess jointly under Art. 67 IVDR; KME delivers its opinion within 30 days of validation; point (a) studies may start only after 30 days from validation, point (b) after JAZMP approval notice, in both cases absent a negative KME opinion.

Conditions
  • Application may be in Slovenian or English (Art. 7(3)).

Effective from 2025-06-19

Fee: EUR 2,000 (point (a)) / EUR 4,175 (point (b)) per Tarifa Art. 17

Device definition & scope

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

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In-house device conditions

scope.in-house-conditions
Fact-level verified

Health institutions manufacturing in-house devices must publish an 'Izjava o proizvodnji in uporabi internih pripomočkov' on their website; the documentation duty of Art. 5(5)(g) extends beyond class D also to in-house class B and C devices; units producing in-house IVDs must meet at least SIST EN ISO 15189; JAZMP may demand documentation to verify conformity.

Conditions
  • In addition to Art. 5(5) MDR / Art. 5(5) IVDR conditions for in-house exemption.

Effective from 2025-06-19

Single-use device reprocessing

scope.reprocessing-conditions
Fact-level verified

Reprocessing of single-use devices is allowed only within the same health institution, or by an external processor seated in Slovenia that returns the fully reprocessed device to that institution; the device must be on the JAZMP list of devices permitted for reprocessing; the institution bears manufacturer-type obligations; reprocessed single-use devices may not be placed on the market.

Conditions
  • Art. 17 MDR conditions must additionally be satisfied.
  • External processor needs a valid notified-body certificate and written agreement with the institution.
  • JAZMP decides on listing within 30 days of a proposal.

Effective from 2025-06-19

Dossier requirements

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

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Submission language

dossier.submission-language
Fact-level verified

Applications filed with JAZMP must be in Slovenian; exceptions (Slovenian or English allowed): exceptional-approval applications under Art. 8, clinical investigation applications (Art. 70 MDR), performance study applications (Art. 66 IVDR) and notified-body nomination applications.

Effective from 2025-06-19

Economic-operator roles

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

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Distributor and health-institution responsible persons

roles.distributor-hcu-compliance-person
Fact-level verified

Health institutions and distributors (except distributors offering only the devices exempted under Art. 21(4)) must have a person responsible for regulatory compliance and a person responsible for reporting vigilance incidents; qualification requires at least one year of experience with regulatory requirements or a device-related quality-management system; the compliance person keeps records of tasks performed.

Conditions
  • One person may hold both roles.
  • Distributors and micro/small importers need not employ the persons but must have them permanently and continuously available.

Effective from 2025-06-19

Importer responsible persons

roles.importer-prrc-vigilance-person
Fact-level verified

Importers must have in-house at least one person responsible for regulatory compliance and at least one person responsible for reporting vigilance incidents; qualification: an 8th-level (second-cycle) diploma in law, medicine, pharmacy, engineering or another science, or at least one year of experience with regulatory requirements or a quality-management system for medical devices.

Conditions
  • National extension beyond MDR Art. 15 (which obliges manufacturers only).
  • Micro and small enterprises need not employ the persons but must have them permanently and continuously available.

Effective from 2025-06-19

Confirmed on JAZMP importer page (res-si-jazmp-uvozniki)

Establishment, import & distribution

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

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Distributor registration

establishment.distributor-registration
Fact-level verified

A distributor seated in Slovenia must register in the JAZMP information system before starting activity on the Slovenian market; JAZMP registers the distributor within five days of a complete application; changes or cessation must be reported within 8 days; once a year the distributor must confirm data accuracy within a stated deadline of at least 30 days or face deletion from the register.

Conditions
  • Exempt: distributors making available only the devices listed in Art. 21(4) ZMedPri-1.
  • Registration data (except contacts) are public.

Effective from 2025-06-19

National duty beyond EU distributor rules; filing via SPOT portal costs nothing (res-si-spot-distributor)

Importer registration and duties (interim, until EUDAMED)

establishment.importer-registration-interim
Fact-level verified

Until EUDAMED begins functioning, an importer seated in Slovenia must register with JAZMP before starting activity; at each first supply it submits the EU declaration of conformity and certificate, reports every purchase of devices to be placed on the Slovenian market, and keeps UDI records for supplied devices regardless of risk class; changes/cessation are notified within 8 days.

Conditions
  • Interim provision (Chapter on prehodne določbe).
  • Registration data (except contacts) are public.

Effective from 2025-06-19

Manufacturers, authorised representatives and system/procedure-pack producers register under parallel interim Articles 42-44

Custom-made, reprocessor and in-house registration

establishment.niche-operator-registration
Fact-level verified

Manufacturers of custom-made devices seated in Slovenia, health institutions reprocessing single-use devices, and health institutions producing in-house devices must register in the JAZMP information system before starting the activity; JAZMP registers them within five days of the application; changes/cessation within 8 days; annual data confirmation with a deadline of at least 30 days.

Conditions
  • Operators already registered under the old ZMedPri had to re-register in the new information system within three months of ZMedPri-1 entry into force (Art. 49).

Effective from 2025-06-19

Retail sale to laypersons

establishment.retail-layperson-advisor
Fact-level verified

Laypersons may obtain devices only in primary-level pharmacy units or shops defined by trade law; these must employ an 'oseba za strokovno svetovanje' advice person (at least secondary education, EQF level 5) present throughout opening hours; professional-use devices reach laypersons only via health workers; remote sellers must offer remote professional advice.

Conditions
  • Sale without an advisor is allowed only for Class I devices supplied without IFU (MDR Annex I 23.1(d)), equivalent IVDs (IVDR Annex I 20.1(d)), and devices on a JAZMP exemption list based on risk assessment.
  • IVD self-tests for infectious diseases may be sold only by the advice person.
  • In disasters/crises JAZMP may ban sale without an advisor.

Effective from 2025-06-19

Fees

What regulator fee applies to this class, route, event, and date?

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Annual fee obligation

fees.annual-fee-obligation
Fact-level verified

Under Art. 32 ZMedPri-1, applicants pay JAZMP a fee for procedures under the act and the two regulations, and notified bodies, manufacturers, authorised representatives, importers, distributors (except Art. 21(4)-only distributors), custom-made manufacturers, reprocessors and in-house-producing health institutions pay JAZMP annual fees funding system maintenance and market surveillance; the fee basis is net annual revenue from device activity (total net revenue without separate accounting); amounts and payment methods are set in the Tarifa issued by the JAZMP council.

Conditions
  • Current Tarifa: UL RS 6/26, in force from 31 January 2026; first year charged pro rata (1/12 per month).

Effective from 2025-06-19

Fee amounts recorded as typedFindings against the Tarifa (res-si-tarifa-jazmp-2026)

No fee for distributor/importer registration

fees.no-fee-distributor-registration
Fact-level verified

The national distributor/importer registration procedure with JAZMP (and its change/deletion procedures) charges no procedural cost: the SPOT government page states 'Stroškov postopka ni.'

Conditions
  • Distinct from the annual fees owed by distributors under Art. 32 ZMedPri-1 and the Tarifa.

Label, IFU & language

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

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Slovenian mandatory for layperson-facing documents

language.ifu-layperson-slovene
Fact-level verified

The following must be in Slovenian: labels and instructions for use (MDR Annex I section 23 / IVDR Annex I section 20) intended for laypersons (nestrokovnjaki), field safety corrective action notices, clinical investigation summaries, and documents used to obtain informed consent.

Effective from 2025-06-19

Professional-use IFU language and translation duty

language.ifu-professional-translation
Fact-level verified

Labels and instructions for professionally-used devices must be in Slovenian or another language understandable to the user; if the instructions for use are not in Slovenian, the supplier must, at a health institution's request, immediately and at the latest within ten days provide the instructions for use in Slovenian.

Conditions
  • Fine for failing to provide the Slovenian translation: EUR 800-4,000 for legal persons (Art. 36(1)(1)).

Effective from 2025-06-19

Slovenian or English for technical documents

language.technical-docs-slovene-or-english
Fact-level verified

Conformity documentation, the EU declaration of conformity, certificates, labels and instructions for use for professional users (MDR Annex I section 23 / IVDR Annex I section 20), software interfaces and the technical documentation referenced in the regulations may be in Slovenian or English.

Effective from 2025-06-19

Manufacturer PMS

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

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PSUR submission (interim, until EUDAMED)

pms.psur-interim
Fact-level verified

Until EUDAMED functions, RS-seated manufacturers and authorised representatives must submit periodically updated safety reports for class III devices and implantable devices to the notified body involved in the conformity assessment; the reports and the notified body's evaluations are available on request to JAZMP and the competent authorities of EU member states.

Conditions
  • Interim provision ending with EUDAMED functioning.

Effective from 2025-06-19

Official forms & portals

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

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EUDAMED Actors module route

forms.eudamed-actors-module
Fact-level verified

Manufacturers and importers register electronically via 'Registracija v EUDAMED (Actors Modul)'; a signed 'Izjava o odgovornosti za informacijsko varnost' must be uploaded (signed with a qualified digital certificate such as SIGEN-CA, SI-PASS; hand-signed originals go by post to JAZMP, Slovenčeva ulica 22, Ljubljana); JAZMP assigns the SRN; the declared risk class must be stated; cessation is reported with form Obr. 861-03 within 8 days.

Conditions
  • Micro and small enterprises must have the compliance person permanently available rather than employed.

Same route documented for importers on res-si-jazmp-uvozniki

SPOT portal registration

forms.spot-distributor-registration
Fact-level verified

Distributor/importer registration applications with JAZMP are filed electronically via the Slovenska poslovna točka (SPOT) government portal (or physically to JAZMP); any person authorised by the business entity may submit; changes and deletions are filed the same way; legal remedy is an appeal decided by the Ministry of Health.

Conditions
  • For business entities seated in Slovenia performing distribution/import activities.

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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Inspector powers and enforcement

recall.inspector-measures
Fact-level verified

JAZMP inspectors (pharmaceutical inspectors) supervise the field; on finding violations they may prohibit the business entity's activity, restrict/ban/condition making devices available, order withdrawal or recall of a device posing unacceptable risk, seize or destroy devices, ban a clinical investigation or performance study, suspend or revoke notified-body designations, require data and take free samples; an appeal against inspector measures does not stay their enforcement.

Conditions
  • Patient-implant-information supervision (Art. 11(1)-(2)) lies with the health inspectorate; trade conditions (Art. 21(2)) with the trade inspectorate.

Effective from 2025-06-19

Registration pathways

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

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National device registration (interim, until EUDAMED)

registration.device-register-interim
Fact-level verified

Until the corresponding EUDAMED systems function, a manufacturer or authorised representative seated in Slovenia must submit to JAZMP a registration application for each non-custom-made device before placing it on the market; the application contains 16 items including trade name, GMDN/EU nomenclature code, risk class, basic UDI-DI, and safety/performance summary for class C and D, plus a copy of the notified-body certificate where applicable.

Conditions
  • Applies until JAZMP announces on its website that the EUDAMED device registration, UDI database and notified-body/certificate systems are available (Art. 45(8)).
  • Devices already registered under the old ZMedPri are exempt.
  • Changes and cessation must be reported within 8 days.

Effective from 2025-06-19

Transitional chapter provision (until EUDAMED functioning per Art. 123(e) MDR)

Free-sale certificate

registration.free-sale-certificate
Fact-level verified

JAZMP issues the free-sale certificate (certifikat o prosti prodaji) to manufacturers or authorised representatives seated in Slovenia within 30 days of receiving a complete application, on the basis of Art. 60 MDR and Art. 55 IVDR; application content is set by a JAZMP general act with the health minister's consent.

Conditions
  • Fee: EUR 150 for the first certificate, EUR 50 for each additional (Tarifa UL RS 6/26).

Effective from 2025-06-19

Market-access route or official registration surface

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

EUDAMED shared layer plus JAZMP national registration and forms: manufacturers/importers/authorised representatives register via the EUDAMED Actors module routed through JAZMP (SRN issued by JAZMP); distributors and importers may file national registration via the SPOT e-portal; devices of RS-seated manufacturers/ARs were registered nationally under Art. 45 ZMedPri-1 until the corresponding EUDAMED modules function

Verified Highlights
  • JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigation and free-sale certificates.
  • The current national basis includes the Medical Devices Act ZMedPri-1 (UL RS 40/25); EUDAMED device registration transition ends 28 November 2026.

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.

Slovenia 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 Slovenia (3 records)

SloveniaEU 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-slovenia
Fact-level verified
Target

geo:svn

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
  • Slovenian language duties, JAZMP registrations under ZMedPri-1, EUDAMED actor registration and the JAZMP vigilance channel still apply

The Zakon o medicinskih pripomočkih (ZMedPri-1), Uradni list RS 40/25, in force since 19 June 2025, is the Slovenian implementation act for MDR, IVDR and Regulation 2022/123. It sets competent authorities, language rules, registrations and supervision.

SloveniaUS 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

SloveniaNMPA

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

slovenia

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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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
  • 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

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 approval

special-access.exceptional-approval
Fact-level verified

Under Art. 59 MDR / Art. 54 IVDR, JAZMP may exceptionally authorise placing on the market or putting into use in Slovenia a device for which no conformity-assessment procedure has been carried out, primarily in emergencies where use serves public-health protection or user safety/health; JAZMP decides within 60 days of a complete application; application content is set by a JAZMP general act with health-minister consent.

Conditions
  • Fee charged at EUR 150 per hour of handling, 50% advance (Tarifa Art. 19).

Effective from 2025-06-19

Application may be in Slovenian or English (Art. 7(3))

Submission communications & appeal

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

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Appeal route

appeal.ministry-decides
Fact-level verified

JAZMP decides administrative matters at first instance under the general administrative procedure act (ZUP); appeals against JAZMP decisions are decided by the Ministry of Health.

Effective from 2025-06-19

Confirmed on the SPOT portal page: 'Oblika pravnega varstva: Pritožba' decided by Ministrstvo za zdravje

Offence fine ranges

sanctions.fine-ranges
Fact-level verified

Minor offences under ZMedPri-1 (60 listed violations, e.g. failing to provide the Slovenian IFU translation, not reporting data changes, lacking compliance/vigilance persons): fines EUR 800-4,000 for legal persons, 500-3,000 for sole traders, 200-1,000 for responsible persons, 100-500 for individuals; serious offences (78 listed, mainly substantive MDR/IVDR breaches incl. not reporting serious incidents to JAZMP): EUR 8,000-120,000 for legal persons, 5,000-50,000 sole traders, 500-5,000 responsible persons, 400-4,000 individuals.

Conditions
  • Fast-track offence proceedings may impose a fine above the statutory minimum (Art. 38).

Effective from 2025-06-19

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
Submission Surface

EUDAMED shared layer plus JAZMP national registration and forms: device registration moves to the EUDAMED device module (transition ends 28 November 2026 per Commission Decision (EU) 2025/2371); until then RS-seated manufacturers/ARs file Art. 45 national applications including the basic UDI-DI, and interim importers keep UDI records for supplied devices

Verified Highlights
  • JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigation and free-sale certificates.
  • The current national basis includes the Medical Devices Act ZMedPri-1.

· Effective until 2026-11-28

effectiveTo reflects the EUDAMED device-registration transition end date stated by JAZMP

Vigilance & incident reporting

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

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Health-worker reporting of suspected serious incidents

vigilance.health-worker-48h
Fact-level verified

A health worker reports to JAZMP any suspected serious incident with a device (within the meaning of Art. 87(1)(a) MDR / Art. 82(1) IVDR) through the information system, as soon as possible and at the latest within 48 hours of establishing or becoming aware of the serious incident.

Conditions
  • With the worker's consent JAZMP may share the worker's name/contacts with the business entity for investigation; the health institution must give access to the implicated device or provide a sample of an identical device.

Effective from 2025-06-19

National delta on top of manufacturer/AR vigilance duties in the EU regulations

Vigilance reporting route (interim, until EUDAMED)

vigilance.interim-reporting-fsca
Fact-level verified

Until EUDAMED begins functioning, RS-seated manufacturers and authorised representatives report serious incidents occurring in the EU to the member state where the incident occurred and to the notified body that issued the certificate; field safety corrective actions on EU-market devices (and third-country FSCA whose reason is not limited to that market) are reported to JAZMP, the member-state authority and the notified body; final investigation reports go to the member state where the incident occurred; trend reports to the member states where incidents occurred.

Conditions
  • JAZMP publishes received field safety corrective action notices on its website.

Effective from 2025-06-19

National reporting channel

vigilance.jazmp-reporting-channel
Fact-level verified

JAZMP operates the national vigilance channel: vigilance-system participants report serious incidents with devices occurring in Slovenia to JAZMP (online web form available for actual or suspected serious incidents); the manufacturer or authorised representative must notify field safety corrective actions to both JAZMP and the users of the devices.

Related structured datasets

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

slovenia:medical-device

Jurisdiction Id

slovenia

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

JAZMP

Official Domains
  • jazmp.si
  • eur-lex.europa.eu
  • europa.eu
Source Status

official-source-verified

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 Slovenia registration →
Country

Slovenia

Jurisdiction Id

slovenia

Country Code

SI

Flag

🇸🇮

Regulator

Agency for Medicinal Products and Medical Devices

Regulator Abbrev

JAZMP

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)
  • Distributor registration within 5 days of starting activity
  • Exceptional (compassionate) use authorisation decided within 60 days; free-sale certificate within 30 days
  • Clinical investigation in Slovenia: KME (ethics) opinion within 30 days; change notifications within 8 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 JAZMP. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    JAZMP 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. JAZMP may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, JAZMP issues Slovenia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

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

slovenia

Country

Slovenia

Country Code

SI

Authority

JAZMP

Low Risk Local
Min

150

Max

150

Currency

EUR

Per Product

No

High Risk Local
Min

50000

Max

50000

Currency

EUR

Per Product

No

Details
  • Id

    nb-annual-fee

    Item

    Notified-body annual fee

    Currency

    EUR

    Amount Local

    50000

    Amount Local Formatted

    EUR 50,000

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    nb-evaluation-designation

    Item

    Notified-body evaluation and (re)designation

    Currency

    EUR

    Amount Local

    70000

    Amount Local Formatted

    EUR 70,000

    Frequency

    Per procedure

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    nb-scope-extension

    Item

    Notified-body scope extension

    Currency

    EUR

    Amount Local

    1000

    Amount Local Formatted

    EUR 1,000

    Frequency

    Per code

    Notes

    Minimum EUR 5,000.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    manufacturer-annual-fee

    Item

    Manufacturer annual fee by net revenue and risk class

    Currency

    EUR

    Amount Local

    8000

    Amount Local Min

    800

    Amount Local Max

    14000

    Amount Local Formatted

    EUR 800–14,000

    Frequency

    Per year

    Notes

    Class I/A vs higher class: 800/1,500 (0–60k), 1,200/2,500 (60–350k), 2,000/5,000 (350–700k), 4,000/8,000 (700k–4M), 6,000/10,000 (4–8M), 8,000/14,000 (over 8M).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    authorised-representative-annual-fee

    Item

    Authorised-representative annual fee by net revenue

    Currency

    EUR

    Amount Local

    2000

    Amount Local Min

    2000

    Amount Local Max

    8000

    Amount Local Formatted

    EUR 2,000–8,000

    Frequency

    Per year

    Notes

    EUR 2,000 (0–1M), EUR 4,000 (1–10M), EUR 8,000 (over 10M).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    custom-made-manufacturer-annual-fee

    Item

    Custom-made-device manufacturer annual fee

    Currency

    EUR

    Amount Local

    800

    Amount Local Formatted

    EUR 800

    Frequency

    Per year

    Notes

    Exempt if revenue from the activity is below EUR 20,000.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    distributor-annual-fee

    Item

    Distributor annual fee by net revenue

    Currency

    EUR

    Amount Local

    350

    Amount Local Min

    350

    Amount Local Max

    4500

    Amount Local Formatted

    EUR 350–4,500

    Frequency

    Per year

    Notes

    350 / 800 / 1,500 / 2,500 / 3,500 / 4,500 by revenue band.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    importer-annual-fee

    Item

    Importer annual fee by net revenue

    Currency

    EUR

    Amount Local

    800

    Amount Local Min

    800

    Amount Local Max

    5000

    Amount Local Formatted

    EUR 800–5,000

    Frequency

    Per year

    Notes

    800 / 1,400 / 2,500 / 3,000 / 4,000 / 5,000 by revenue band.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    importer-distributor-annual-fee

    Item

    Combined importer+distributor annual fee by net revenue

    Currency

    EUR

    Amount Local

    1100

    Amount Local Min

    1100

    Amount Local Max

    7000

    Amount Local Formatted

    EUR 1,100–7,000

    Frequency

    Per year

    Notes

    1,100 / 2,000 / 3,000 / 4,000 / 5,000 / 7,000 by revenue band.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    reprocessor-annual-fee

    Item

    Single-use-device reprocessor annual fee

    Currency

    EUR

    Amount Local

    3500

    Amount Local Formatted

    EUR 3,500

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    in-house-production-annual-fee

    Item

    Health-institution in-house production annual fee

    Currency

    EUR

    Amount Local

    2500

    Amount Local Formatted

    EUR 2,500

    Frequency

    Per year

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    free-sale-certificate

    Item

    Free-sale certificate

    Currency

    EUR

    Amount Local

    150

    Amount Local Formatted

    EUR 150

    Frequency

    Per certificate

    Notes

    Each additional certificate: EUR 50. Priority handling (10 days): EUR 250 first, EUR 80 additional.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    clinical-investigation-application

    Item

    Clinical-investigation application

    Currency

    EUR

    Amount Local

    4175

    Amount Local Min

    2000

    Amount Local Max

    4175

    Amount Local Formatted

    EUR 2,000–4,175

    Frequency

    Per application

    Notes

    EUR 2,000 (Art. 62(a) MDR-type) / EUR 4,175 (Art. 62(b)-type), higher by EUR 2,000 if the device incorporates a medicinal substance or human/animal tissue. Substantial modification: EUR 800 / 1,900. Art. 74 application: EUR 2,000 (change 800); Art. 26 ZMedPri-1: EUR 2,000 (change 800). Re-application after rejection 50% lower; lapsed/rejected applications charged at 15%.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    performance-study-application

    Item

    IVD performance-study application

    Currency

    EUR

    Amount Local

    4175

    Amount Local Min

    2000

    Amount Local Max

    4175

    Amount Local Formatted

    EUR 2,000–4,175

    Frequency

    Per application

    Notes

    EUR 2,000 (Art. 58(a) IVDR-type) / EUR 4,175 (point (b)); substantial modification EUR 800 / 1,900; re-application 50% lower; lapsed/rejected 15%.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    nb-dispute-decision

    Item

    Decision in a manufacturer/notified-body dispute

    Currency

    EUR

    Amount Local

    5000

    Amount Local Formatted

    EUR 5,000

    Frequency

    Per decision

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

  • Id

    exceptional-approval-handling

    Item

    Exceptional-approval handling

    Currency

    EUR

    Amount Local

    150

    Amount Local Formatted

    EUR 150

    Frequency

    Per hour

    Notes

    50% advance; listing a device on the reprocessing list is also EUR 150 per hour.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Source Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Source Effective Date

    2026-01-31

    Verified On

    2026-08-25

Notes
  • The Tarifa JAZMP entered into force on 31 January 2026 and replaced the Pravilnik o pristojbinah (UL RS 24/19, 40/25).
  • In the first year, annual fees are levied pro rata at 1/12 per month of activity.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Slovenia JAZMP Tarifa (UL RS 6/26)

    Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0198

    Effective Date

    2026-01-31

    Accessed Date

    2026-08-25

  • Title

    Slovenia: cessation of the previous device-fee rulebook (UL RS 24/19, 40/25)

    Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2026-01-0158/pravilnik-o-prenehanju-veljavnosti-pravilnika-o-pristojbinah-na-podrocju-medicinskih-pripomockov

    Effective Date

    2026-01-31

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

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

slovenia

Market

Slovenia

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

    pravilnik-o-radijski-opremi-red

    Name

    Pravilnik o radijski opremi

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Article 1(1) of the pravilnik published at Uradni list RS 3/2016 sets the requirements for making radio equipment available on the market and putting it into service in accordance with Directive 2014/53/EU, issued under the technical requirements and conformity assessment act ZTZPUS-1. No national type approval appears in it. AKOS does adopt a national frequency use plan setting Slovenian spectrum conditions, which is a spectrum instrument rather than a product approval. Only the opening articles were read and later amendments were not checked; the competent surveillance body is not established from this text.

    Source Urls
    • https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2016-01-0141/pravilnik-o-radijski-opremi
    Source Binding

    reviewed

  • Id

    uredba-oeeo-evidenca-proizvajalcev

    Name

    Evidenca proizvajalcev registration

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Producer Or Authorised Representative

    Note

    Article 17(1) of the uredba published at Uradni list RS 55/2015 obliges a producer, other than the article 3(19d) category, to enter the register of producers kept under article 44, which the ministry maintains to monitor producer duties and into which it enters producers and authorised representatives on application, issuing a certificate of entry. The duty is unconditional but the text read does not make entry a precondition for placing equipment on the market; the nearest gate is article 24(3)(1), under which the ministry confirms a producer's WEEE management plan only if the producer is in the register. 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 Binding

    unresolved

  • Id

    radiation-practice-and-source-use-licences

    Name

    Radiation practice licence and source-use licence

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Practice And Source

    Note

    Uredba o sevalnih dejavnostih (Uradni list RS 19/2018), issued under ZVISJV-1, art. 12 requires a licence to carry out a radiation practice for, among others, using X-ray devices, radiation sources and particle accelerators other than electron microscopes, intentionally adding radioactive substances when producing consumer goods or medicines and importing or exporting such items, and administering radioactive substances to persons for medical purposes. Art. 16 layers a separate source-use licence on high-activity sealed sources, X-ray devices operating above 160 kV where the radiation protection assessment rates the risk as high, particle accelerators and open sources above the exemption level; other sources must be entered in the register of radiation sources before use, and the licence application must already include the valid radiation practice licence.

    Source Urls
    • https://www.uradni-list.si/_pdf/2018/Ur/u2018019.pdf
    Source Binding

    candidate

  • Id

    pravilnik-rohs-ul-rs-102-2012

    Name

    Pravilnik o omejevanju uporabe določenih nevarnih snovi v EEO

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    Read from the as-enacted text in Uradni list RS 102/2012 (sop 2012-01-3952), issued by the minister of health under article 5 of the act on technical requirements for products. Article 2 applies the pravilnik to the Annex I categories of Directive 2011/65/EU and excludes active implantable medical devices. Article 4 (pogoji za dajanje na trg) forbids placing on the Slovenian market electrical and electronic equipment, cables and repair, reuse, upgrade or capacity-increase spare parts containing the Annex II substances above the concentration limits in homogeneous materials; the same article then carves out medical devices placed on the market before 22 July 2014 and in vitro diagnostic medical devices placed on the market before 22 July 2016, which is the national restatement of the Union dates rather than a Slovenian delay. There is no separate Slovenian RoHS certificate: conformity is shown by the EU declaration and CE marking under the internal-production-control procedure in the following articles. Later amendments (including UL RS 60/2016) exist; this row is sourced to the 2012 enactment that still carries the medical-device dates and the active-implantable exclusion. 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 Urls
    • https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2012-01-3952
    Source Binding

    reviewed

  • Id

    uredba-baterije-2024-article-54-authority

    Name

    Uredba o izvajanju Uredbe (EU) o baterijah in odpadnih baterijah

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Battery Producer Or Authorised Representative

    Note

    Unlike the Czech and Bulgarian battery acts, Slovenia has already designated the national authorities for Regulation (EU) 2023/1542. The uredba published at Uradni list RS 83/2024 (2024-01-2498) article 2(2) names the ministry responsible for the environment as the competent authority under Article 54 of the Regulation, article 2(1) names the ministry responsible for the market as the notifying authority under Article 22, and article 2(3) gives the Chemicals Office articles 6 and 86. Article 3 is the practical overlay: the EU declaration of conformity, the instructions and the waste-prevention information required by the Regulation must be in Slovenian. Distributors are fined if they make a battery available without checking that the producer is registered in the Article 55 register (the uredba's penalty provisions cite Article 42(2)(a) of the Regulation). The register itself is the Union-law register, not a second Slovenian list. 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://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2024-01-2498/uredba-o-izvajanju-uredbe-eu-o-baterijah-in-odpadnih-baterijah
    Source Binding

    reviewed

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

    Uradni list Republike Slovenije

    Topic

    Pravilnik o radijski opremi (UL RS 3/2016) 1. člen — RED scope

    Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2016-01-0141/pravilnik-o-radijski-opremi

  • Authority

    Uradni list Republike Slovenije

    Topic

    Uredba o odpadni električni in elektronski opremi (UL RS 55/2015) 17. and 44. člen — producer register

    Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2015-01-2350/uredba-o-odpadni-elektricni-in-elektronski-opremi

  • Authority

    Uradni list Republike Slovenije

    Topic

    Uredba o sevalnih dejavnostih — radiation practice and source-use licences

    Url

    https://www.uradni-list.si/_pdf/2018/Ur/u2018019.pdf

  • Authority

    SPOT (Government of the Republic of Slovenia)

    Topic

    source-use licence and register entry procedure, competent authorities and fee

    Url

    https://spot.gov.si/sl/dejavnosti-in-poklici/dovoljenja/dovoljenje-za-uporabo-vira-sevanja

  • Authority

    Uradni list Republike Slovenije

    Topic

    Pravilnik o omejevanju uporabe določenih nevarnih snovi v električni in elektronski opremi, UL RS 102/2012, articles 2 and 4

    Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2012-01-3952

  • Authority

    Uradni list Republike Slovenije

    Topic

    Uredba o izvajanju Uredbe (EU) o baterijah in odpadnih baterijah, UL RS 83/2024, articles 2 and 3

    Url

    https://www.uradni-list.si/glasilo-uradni-list-rs/vsebina/2024-01-2498/uredba-o-izvajanju-uredbe-eu-o-baterijah-in-odpadnih-baterijah

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