JAZMP · Europe

Slovenia medical device regulatory resources

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

5 free resources24/25 requirements coveredAug 2026 fees reviewed

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Medical device regulation news

Follow recent Agency for Medicinal Products and Medical Devices (JAZMP) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary JAZMP risk class with official rule references.

Government registration fees

Review current JAZMP application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Slovenia requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 41 source-linked facts →

24 of 25 research dimensions currently covered · 22 official sources · latest verification 2026-08-30

Market entry

D01

Authority & regime

Verified

Competent authority: Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP, Agency for Medicinal Products and Medical Devices) is the competent authority implementing ZMedPri 1, Regulat…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National implementation act: Zakon o medicinskih pripomočkih (ZMedPri 1), published in Uradni list RS No. 40/2025 on 4 June 2025 and in force from 19 June 2025, is the national act implementing MDR, IVDR and Regulation…
Official legal and guidance surface: authority: Agency for Medicinal Products and Medical Devices (JAZMP) · submissionSurface: EUDAMED shared layer plus JAZMP national registration (SPOT portal for distributors/importers, EUDA…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

In-house device conditions: 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 be…
Single-use device reprocessing: 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 insti…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

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

1 maintained scheme

Checked 2026-08-26

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D05

Registration pathways

Verified

Market-access route or official registration surface: submissionSurface: EUDAMED shared layer plus JAZMP national registration and forms: manufacturers/importers/authorised representatives register via the EUDAMED Actors module routed through…
National device registration (interim, until EUDAMED): 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 dev…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EU CE under MDR/IVDR — single market validity: target: geo:svn · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

1 source-linked fact

Checked 2026-08-30

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D07

Economic-operator roles

Verified

Importer responsible persons: 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 (se…
Distributor and health-institution responsible persons: 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 responsi…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Distributor registration: 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 comple…
Retail sale to laypersons: 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 educ…

4 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Submission language: Applications filed with JAZMP must be in Slovenian; exceptions (Slovenian or English allowed): exceptional approval applications under Art. 8, clinical investigation applications (Art. 70 M…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

SPOT portal registration: Distributor/importer registration applications with JAZMP are filed electronically via the Slovenska poslovna točka (SPOT) government portal (or physically to JAZMP); any person authorised…
EUDAMED Actors module route: 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 qu…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Slovenian mandatory for layperson-facing documents: 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 acti…
Professional-use IFU language and translation duty: 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 m…

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Manufacturer quality management system (Art. 10(9)): 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 effe…

1 source-linked fact

Checked 2026-08-29

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D13

Standards, testing & ancillary approvals

Verified

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Pravilnik o radijski opremi: Wireless / radio

7 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

Notified-body annual fee: EUR 50,000
Notified-body evaluation and (re)designation: EUR 70,000

16 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Device registration validity: 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 EU…

1 source-linked fact

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Change notification deadline: 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 represen…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Official UDI or listing surface: submissionSurface: EUDAMED shared layer plus JAZMP national registration and forms: device registration moves to the EUDAMED device module (transition ends 28 November 2026 per Commission D…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation assessment with KME: 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…
Performance study assessment with KME: 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 unde…

3 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Exceptional approval: 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 carr…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

PSUR submission (interim, until EUDAMED): 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…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Health-worker reporting of suspected serious incidents: 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…
Vigilance reporting route (interim, until EUDAMED): 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…

3 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Inspector powers and enforcement: JAZMP inspectors (pharmaceutical inspectors) supervise the field; on finding violations they may prohibit the business entity's activity, restrict/ban/condition making devices available, or…

1 source-linked fact

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising restricted to professional public: 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 pro…
Gifts and samples restrictions: 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…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeal route: 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.
Offence fine ranges: 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…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (16 lines) →

JAZMP registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
Notified-body annual fee	EUR 50,000	Verified
Notified-body evaluation and (re)designation	EUR 70,000	Verified
Notified-body scope extension	EUR 1,000	Verified
Manufacturer annual fee by net revenue and risk class	EUR 800–14,000	Verified