Pure Global AI
ŠÚKL · structured requirements

🇸🇰 Slovakia medical device regulatory data

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

35 facts23 dimensions13 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

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

Compare countries

Misleading claims prohibition (Art. 7)

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

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

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

Effective from 2021-05-26

Approval validity & renewal

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

Compare countries

Distributor registration valid 5 years

validity.distributor-registration-5-years
Fact-level verified

A distributor registration with ŠÚKL is valid for 5 years; after expiry the registration ends and the entity is removed from the public list of registered distributors. Continuing requires a new registration and a new fee.

Conditions
  • Applies to § 110a distributor registrations.

Effective from 2021-05-26

Fee 500 € (450 € for fully electronic filing) per registration period.

Authority & regime

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

Compare countries

Competent authority

authority.competent-authority
Fact-level verified

Štátny ústav pre kontrolu liečiv (ŠÚKL, State Institute for Drug Control) is the national competent authority overseeing the safety, quality and effectiveness of medicines and medical devices in Slovakia, including IVDs.

Conditions
  • Applies to all device classes and IVDs.

ŠÚKL homepage tagline verified on www.sukl.sk on 2026-08-25.

Medical Devices Section within ŠÚKL

authority.medical-devices-section
Fact-level verified

The Medical Devices Section (Sekcia zdravotníckych pomôcok) of ŠÚKL runs the national device agenda: intake of registrations/notifications of devices and IVDs, market surveillance and inspections, vigilance, and clinical-investigation / IVD performance-study permissions. Published contacts: pomocky@sukl.sk, vigilanciazp@sukl.sk, clinical-investigation-md@sukl.sk.

Conditions
  • Applies to medical devices and IVDs.

Section headed by PharmDr. Zuzana Baťová, PhD.; departments include Oddelenie trhového dohľadu a vigilancie and Oddelenie príjmu dokumentácie.

Change control

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

Compare countries

Change notification to ŠÚKL

change.hlasenie-zmeny-duty
Fact-level verified

Changes to nationally notified/registered data are reported to ŠÚKL by filing a hlásenie zmeny (change report), which is a charged service under the ŠÚKL Sadzobník výkonov a služieb; the same schedule charges device-code creation/update requests and technical-documentation assessment. For clinical investigations, assessment of a substantial-change notification is separately charged (500 €, sadzobník item 96.1.58).

Conditions
  • Applies to changes after national notification/registration and to substantial changes of an authorised clinical investigation.

Sadzobník fees are invoiced after the service is performed.

Clinical investigation & performance

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

Compare countries

Ethics committee opinion gates the authorisation

clinical.ethics-committee-gate
Fact-level verified

ŠÚKL will not issue the clinical-investigation authorisation decision without a positive ethics committee opinion, and a clinical investigation may not start without it; the opinion is submitted as soon as available. Until the EUDAMED clinical-investigation module is fully functional, applicants use local ethics committees in Slovakia.

Conditions
  • Applies to clinical investigations of medical devices and IVD performance studies in Slovakia.

Ministry of Health statement on the ethics committee procedure is linked by ŠÚKL.

ŠÚKL permission for clinical investigations and IVD performance studies

clinical.investigation-permission-required
Fact-level verified

A clinical investigation of a medical device, or a performance study of an IVD, conducted in Slovakia requires prior authorisation from ŠÚKL: application on form TL SZP 021 (clinical investigation) or TL SZP 066 (IVD performance study) per ŠÚKL methodological guideline MP 147/2024. The investigation may start only after the authorisation decision (Rozhodnutie) becomes final; if the application is refused the 500 € administrative fee is not returned.

Conditions
  • Applies to clinical investigations under MDR Ch. VI and IVD performance studies under IVDR Art. 58–77/borderline performed in Slovakia.
  • Administrative fee 500 € (sadzobník item 96.1.57), paid via eKolok against a payment order issued after receipt of the application.

Finality/start rule per ŠÚKL clinical-investigation information page: 'V prípade povolenia klinického skúšania zdravotníckej pomôcky sa po nadobudnutí právoplatnosti Rozhodnutia môže klinické skúšanie začať.'

Device definition & scope

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

Compare countries

Device definition (MDR Art. 2(1))

device.definition-scope-mdr
Fact-level verified

A medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specified medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; or providing information by means of in vitro examination of specimens derived from the human body), and which does not achieve its principal intended action by pharmacological, immunological or metabolic means. Software intended for medical purposes is itself a device.

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

Dossier requirements

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

Compare countries

National notification/registration dossier

dossier.notification-package
Fact-level verified

The ŠÚKL notification/registration package comprises: (1) cover letter; (2) original power of attorney (Slovak, officially translated, or multilingual with Slovak text); (3) registration/notification data form in 2 copies; (4) annex per device in 2 copies; (5) EU Declaration of Conformity (English, multilingual with English, or translated into Slovak); (6) notified-body certificates (plus 2023/607 transition declarations — manufacturer solemn declarations and NB confirmation letter); (7) instructions for use in Slovak (printed, double-sided, or on electronic carrier if extensive); (8) outer-packaging label artwork in Slovak (photo or physical packaging; missing Slovak data may be added as a sticker with the manufacturer's written consent); (9) fee settlement proposal (Návrh na vyúčtovanie) in 2 signed copies.

Conditions
  • Applies to national notification (§ 110b) and SR-manufacturer registration; reduced to Slovak-only documents not in EUDAMED from 28.5.2026.

Labelling may alternatively use symbols per EN ISO 15223-1 / EN 980; CE mark min. vertical dimension 5 mm.

Economic-operator roles

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

Compare countries

Who may file the national notification

operators.notification-actors-and-power-of-attorney
Fact-level verified

The manufacturer, EC representative, importer or distributor that makes the device available on the Slovak market is the obligated actor for the § 110b notification. If another subject files on their behalf, an original power of attorney from the manufacturer/EC REP/importer/distributor is required.

Conditions
  • Third-party filings require an original splnomocnenie covering the specific act.

Power of attorney accepted in Slovak, officially translated into Slovak, or multilingual with Slovak binding text.

Establishment, import & distribution

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

Compare countries

Distributor registration (§ 110a) — voluntary now, mandatory from 28.5.2026

establishment.distributor-registration-regime
Fact-level verified

Distributors making devices available in Slovakia (any person in the supply chain that is neither manufacturer nor importer; foreign entities included) can register with ŠÚKL under § 110a ods. 3 písm. a) of zákon č. 362/2011 Z. z. (regime effective 26 May 2021). Registration is currently voluntary — distribution without it is lawful — but becomes mandatory at national level from 28 May 2026 for distributors making devices available on the Slovak market regardless of seat. Registered distributors appear in the public alphabetical Zoznam distribútorov ZP/IVD ZP (updated daily).

Conditions
  • Currently voluntary (guidance of 26.5.2021, updated 28.8.2024).
  • Mandatory from 28.5.2026 per ŠÚKL EUDAMED transition notice.
  • No seat in Slovakia required.

Effective from 2021-05-26

Forms TL SZP 070 (application) and TL SZP 026 (cover letter); filing by post/counter or electronically via www.slovensko.sk.

Fees

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

Compare countries

Clinical-investigation fee non-refundable on rejection

fees.ci-non-refundable-on-rejection
Fact-level verified

If ŠÚKL rejects the application for authorisation of a clinical investigation of a medical device, the 500 € administrative fee is not returned. Fees are paid via the eKolok payment system (operated by Slovenská pošta) against a payment order (platobný predpis) issued by ŠÚKL after receipt of the application.

Conditions
  • Applies to sadzobník item 96.1.57 (and analogously 96.1.58/59) under zákon č. 145/1995 Z. z.

eKolok mechanism applies to all section-ZP administrative fees; paying to ŠÚKL's account directly is treated as an invalid payment.

Registration fee non-refundable on refusal

fees.registration-non-refundable
Fact-level verified

The 750 €/430 € ŠÚKL fee for registration/notification by an SR-seated manufacturer or EC representative is payable after filing (against an invoice based on the Návrh na vyúčtovanie) and is a condition of registration; it is not returned if the registration/notification is refused.

Conditions
  • Applies to § 110/§ 110b registrations by SK manufacturers/EC REPs.

Fee rule the fee dataset cannot express; amounts recorded in typedFindings.

Label, IFU & language

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

Compare countries

Slovak-language label and IFU requirement

label-ifu.slovak-state-language
Fact-level verified

The label (označenie/štítok) and, where a device is supplied with one, the instructions for use of a medical device or IVD made available in Slovakia must be in the Slovak language. National legal basis: § 110b ods. 1 of zákon č. 362/2011 Z. z. (alongside MDR Art. 10(11) and IVDR Art. 10(10)). Labelling may alternatively use the symbols of EN ISO 15223-1 or EN 980.

Conditions
  • Applies to devices from foreign manufacturers and to domestic supply alike.
  • Symbols per EN ISO 15223-1 / EN 980 accepted in place of Slovak text on the label.
  • IFU submitted to ŠÚKL in printed form (double-sided; electronic carrier if extensive).

Key national delta over MDR Art. 10(11): Slovakia actually requires Slovak, via § 110b ods. 1.

Manufacturer PMS

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

Compare countries

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

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

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

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

Effective from 2021-05-26

Official forms & portals

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

Compare countries

Filing channels and national forms

official-forms.submission-channels
Fact-level verified

National device filings are made in paper form to ŠÚKL's podateľeňa (counter) or by post, or electronically via the Central Government Portal ÚPVS (www.slovensko.sk). Current ŠÚKL section-ZP forms include TL SZP 021 (clinical investigation application), TL SZP 066 (IVD performance study application), TL SZP 070/026 (distributor registration), TL SZP 075 (serious-incident report), TL SZP 052 (free-sale certificate request) and TL SZP 037 (fee settlement proposal). Administrative fees are paid via the eKolok system against a payment order generated per filing.

Conditions
  • Paper filings need 1 copy of the cover letter; ÚPVS electronic filing follows ŠÚKL's published instructions.

eKolok payment order per MP 148/2025: 'platobný predpis vygenerovaný v systéme eKolok pre toto konkrétne podanie'.

QMS, audit & inspection

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

Compare countries

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?

Compare countries

ŠÚKL vigilance system covers MIR and FSCA

recall-fsca.national-vigilance-system
Fact-level verified

The ŠÚKL medical-device vigilance system serves to report, record and evaluate serious incidents (MIR) and field safety corrective actions (FSCA) with the aim of protecting patients and users. ŠÚKL publishes national field-safety-notice forms: FSN_SK for manufacturers and response forms for distributors (FSN_odpovedny_form_distributor) and customers (FSN_odpovedny_form_zakaznik).

Conditions
  • Applies to devices and IVDs on the Slovak market.

FSCA/FSN notification duties as such follow MDR/IVDR; the national delta is the ŠÚKL system and national FSN forms.

Registration pathways

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

Compare countries

National arrangements when EUDAMED becomes mandatory (28 May 2026)

registration.eudamed-2026-national-arrangements
Fact-level verified

From 28 May 2026 use of the first four EUDAMED modules becomes mandatory (Actor registration; UDI/Devices registration; Notified bodies and certificates; Market Surveillance). Actor registration moves to EUDAMED and manufacturers must register all devices in EUDAMED, but the national notification duty under § 110b is retained: the national dossier shrinks to documents not available in Slovak in EUDAMED (Slovak device name, Slovak IFU, Declaration of Conformity). The Class I / IVD class A exemption continues unless ŠÚKL requests notification. Distributor registration becomes mandatory at national level for distributors making devices available on the Slovak market regardless of seat.

Conditions
  • Effective from 28 May 2026; changes the national filing package but not the duty to notify.

Effective from 2026-05-28

Fee form TL SZP 037 (Návrh na vyúčtovanie) still required among documents.

Free sale certificate issued by ŠÚKL

registration.free-sale-certificate
Fact-level verified

Since 1 August 2023 ŠÚKL is designated to issue Certificates of Free Sale (Certifikát voľného predaja) for medical devices and IVDs under § 129 ods. 2 písm. aj) of zákon č. 362/2011 Z. z. (as amended by zákon č. 293/2023 Z. z.). Request in paper form at ŠÚKL's counter, by post, or electronically via www.slovensko.sk; certificate issued only in paper form in 3 copies; administrative fee 300 €.

Conditions
  • Available to SK manufacturers / SK EC reps for devices compliant with applicable EU legislation; dossier includes DoC and, during the legacy transition (to 31.12.2027/31.12.2028 by class), manufacturer self-declaration and NB confirmation letter.

Effective from 2023-08-01

Fee is sadzobník item č. 152 písm. aj) of the annex to zákon č. 145/1995 Z. z. o správnych poplatkoch.

Market-access route or official registration surface

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

CE conformity under MDR/IVDR plus a national ŠÚKL layer: notification (oznámenie) of devices under § 110b ods. 2 zákona č. 362/2011 Z. z. (with assignment of a national ŠÚKL code); registration (registrácia) for SR-seated IVD manufacturers/EC reps under § 110 ods. 2; EUDAMED actor/device modules become mandatory 28 May 2026 but the national notification duty is retained in reduced form.

Verified Highlights
  • Class I devices (MD) and class A IVDs from foreign manufacturers need not be notified (voluntary).
  • National § 110b notification duty persists alongside EUDAMED from 28.5.2026.
Conditions
  • Route applies on top of EU CE conformity; never a substitute for it.

Upgrades the r187 baseline (which cited EUR-Lex) to ŠÚKL national sources.

No marketing hold pending notification

registration.no-marketing-hold
Fact-level verified

A device from a foreign manufacturer may be supplied and sold in Slovakia while the notification/ŠÚKL-code request is still being processed, provided EU and Slovak device legislation is met; the ŠÚKL code only needs to be awaited when it is required for Ministry of Health categorization (reimbursement listing), for which an urgent processing request is possible.

Conditions
  • Applies where no ŠÚKL code is needed for MZ SR categorization; CE/EU compliance still required.

Notification is therefore an information duty, not a pre-market approval.

14-day notification deadline

registration.notification-deadline-14-days
Fact-level verified

Under § 110b ods. 2 of zákon č. 362/2011 Z. z., the economic operator must notify ŠÚKL within 14 days of first making the device available on the Slovak market.

Conditions
  • Runs from the first making available of the device on the Slovak market.

Deadline restated by ŠÚKL in its 28.5.2026 EUDAMED transition notice.

National notification of devices from manufacturers seated outside Slovakia

registration.notification-foreign-manufacturers
Fact-level verified

Manufacturers of medical devices (including active implantable devices) seated outside Slovakia — and their EC representatives, importers or distributors that make the device available on the Slovak market — must notify the device data to ŠÚKL under § 110b ods. 2 of zákon č. 362/2011 Z. z. Class I devices (MD) and class A IVDs from foreign manufacturers are exempt; notification of them is voluntary, mainly needed for Ministry of Health categorization (reimbursement).

Conditions
  • Applies to devices from manufacturers not seated in Slovakia that are made available on the SR market.
  • Class I (MD) and class A (IVD) exemption confirmed by ŠÚKL FAQ: 'Táto informácia sa týka len ZP od zahraničných výrobcov.'
  • CE conformity and all other EU obligations remain unaffected.

ŠÚKL assigns a national code (ŠÚKL kód) upon completed notification.

Registration of SR-seated IVD manufacturers and EC reps (§ 110)

registration.sr-ivd-manufacturer-registration
Fact-level verified

Manufacturers of in vitro diagnostic devices and their EC representatives seated in Slovakia are subject to registration (registrácia) with ŠÚKL under § 110 ods. 2 of zákon č. 362/2011 Z. z. — for all their IVDs regardless of class, including class A. Filing fee 750 € (plus 430 € for the technical-documentation assessment of each additional device).

Conditions
  • Applies to IVD manufacturers and EC reps with seat in the Slovak Republic.

ŠÚKL checks completeness of technical documentation during registration.

SR-seated manufacturers/EC reps of MDs must cover all classes incl. Class I

registration.sr-zp-manufacturer-all-classes
Fact-level verified

Manufacturers of medical devices (including AIZP) and EC representatives seated in Slovakia notify/register all of their devices with ŠÚKL regardless of classification — including Class I devices — unlike the exemption that applies to foreign manufacturers' Class I devices.

Conditions
  • Applies to manufacturers/EC REPs with seat in the Slovak Republic (ZP and AIZP route under § 110b).

Mirrors the IVD rule for SR-seated manufacturers ('aj zdravotnícke pomôcky triedy I a IVD zdravotnícke pomôcky triedy A').

Reliance & recognition

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

Compare countries

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.

Slovakia 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 Slovakia (3 records)

SlovakiaEU 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-slovakia
Fact-level verified
Target

geo:svk

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
  • Slovak language duties, ŠÚKL notification under §§ 110 to 110b of Zákon č. 362/2011 Z. z., EUDAMED actor registration and the ŠÚKL vigilance channel still apply

Zákon č. 362/2011 Z. z. is the Slovak law of record, with §§ 110, 110a and 110b carrying the device provisions ŠÚKL applies. The national step is notification to ŠÚKL, not approval.

SlovakiaUS 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

SlovakiaNMPA

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

slovakia

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?

Compare countries

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?

Compare countries

In-house health-institution exemption (Art. 5(5))

special-access.in-house-exemption-art-5-5
Fact-level verified

Devices manufactured and used only within health institutions established in the Union are exempt from the requirements of the Regulation, with the exception of the relevant general safety and performance requirements of Annex I, provided that: the devices are not transferred to another legal entity; manufacture and use occur under an appropriate quality management system; the health institution justifies in its documentation that the target patient group's specific needs cannot be met by an equivalent device available on the market; and the institution assumes all responsibilities and obligations established by the Regulation.

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

Submission communications & appeal

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

Compare countries

Deficiency notices (výzvy) served electronically via slovensko.sk

communications.deficiency-notices-electronic-delivery
Fact-level verified

ŠÚKL serves its deficiency notices and other outgoing documents (výzvy) on Slovak legal entities exclusively electronically to their seat address via www.slovensko.sk; Slovak natural persons receive them electronically only if their box is activated (otherwise paper conversion via Central Official Delivery), and foreign applicants without an activated box receive a paper copy of the electronic document. Follow-up documents must quote the case number and handling officer.

Conditions
  • Applies to national device proceedings conducted by ŠÚKL.

Proceedings run under the Administrative Procedure Code (zákon č. 71/1967 Zb.), which ŠÚKL cites including § 30(1)(d) on discontinuation.

UDI, listing & traceability

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

Compare countries

ŠÚKL national device codes

udi-listing.sukl-national-codes
Fact-level verified

Upon national notification/registration ŠÚKL assigns national device codes (ŠÚKL kód), maintained in the ŠÚKL device database (VIS ZP). Codes are the reference needed for Ministry of Health categorization (reimbursement listing); they are not a marketing precondition. Code status can be checked the next working day in the public search database on sukl.sk; ŠÚKL does not issue extracts from the registered/notified device database. From 28 May 2026 device registration moves to EUDAMED (UDI/Devices module mandatory).

Conditions
  • National code layer coexists with EU UDI/EUDAMED duties.

Code assignment is charged per the Sadzobník výkonov a služieb ŠÚKL.

Vigilance & incident reporting

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

Compare countries

Direct reporting of suspected serious incidents by professionals and patients

vigilance.professional-patient-direct-reporting
Fact-level verified

ŠÚKL accepts reports of suspected serious incidents (závažné nehody) and adverse events involving devices from healthcare professionals and from patients in Slovakia, using form TL SZP 075 sent to vigilanciazp@sukl.sk; ŠÚKL processes and evaluates the report and informs the device's manufacturer. Manufacturer MIR reports are made on the European Commission/MDCG forms.

Conditions
  • Channel in addition to the manufacturer's MDR Art. 87 / IVDR Art. 82 duties; manufacturers report via MIR to the competent authority of the incident member state / ŠÚKL.

National reporting channel and national form TL SZP 075 are the Slovak delta on top of MDR/IVDR vigilance.

Related structured datasets

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

slovakia:medical-device

Jurisdiction Id

slovakia

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

ŠÚKL

Official Domains
  • sukl.sk
  • 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 Slovakia registration →
Country

Slovakia

Jurisdiction Id

slovakia

Country Code

SK

Flag

🇸🇰

Regulator

State Institute for Drug Control

Regulator Abbrev

ŠÚKL

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)
  • Class I/IVD national notification: confirmation within 14 days (§ 110b(2) Law 363/2019 as amended); processing up to 90 days
  • Distributor/wholesaler registration within 30 days of starting activity; registration does not expire (5-year re-check)
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 ŠÚKL. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    ŠÚKL 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. ŠÚKL may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, ŠÚKL issues Slovakia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

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

slovakia

Country

Slovakia

Country Code

SK

Authority

ŠÚKL

Low Risk Local
Min

300

Max

300

Currency

EUR

Per Product

No

High Risk Local
Min

750

Max

750

Currency

EUR

Per Product

No

Details
  • Id

    distributor-registration

    Item

    Distributor registration decision (item 96.1.56)

    Currency

    EUR

    Amount Local

    500

    Amount Local Formatted

    EUR 500

    Frequency

    Per registration

    Notes

    EUR 450 when the filing is fully electronic. Paid via eKolok within 30 days.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok

    Source Title

    Slovakia ŠÚKL eKolok: administrative-fee table for devices

    Verified On

    2026-08-25

  • Id

    clinical-investigation-authorisation

    Item

    Clinical-investigation authorisation proceedings (item 96.1.57)

    Currency

    EUR

    Amount Local

    500

    Amount Local Formatted

    EUR 500

    Frequency

    Per application

    Notes

    Not refunded on rejection.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok

    Source Title

    Slovakia ŠÚKL eKolok: administrative-fee table for devices

    Verified On

    2026-08-25

  • Id

    ci-substantial-change-notification

    Item

    Notification of substantial change to a clinical investigation (item 96.1.58)

    Currency

    EUR

    Amount Local

    500

    Amount Local Formatted

    EUR 500

    Frequency

    Per notification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok

    Source Title

    Slovakia ŠÚKL eKolok: administrative-fee table for devices

    Verified On

    2026-08-25

  • Id

    ci-notification-ce-device

    Item

    Notification of a clinical investigation of a CE-marked device (item 96.1.59)

    Currency

    EUR

    Amount Local

    500

    Amount Local Formatted

    EUR 500

    Frequency

    Per notification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok

    Source Title

    Slovakia ŠÚKL eKolok: administrative-fee table for devices

    Verified On

    2026-08-25

  • Id

    free-sale-certificate

    Item

    Free-sale certificate for devices and IVDs (item 152 aj)

    Currency

    EUR

    Amount Local

    300

    Amount Local Formatted

    EUR 300

    Frequency

    Per certificate

    Notes

    Paid via eKolok payment order per filing, not in advance (MP 148/2025).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/buxus/docs/MP_148-2025_Postup_pri_podani_ziadosti_o_vystavenie_Certifikatu_volneho_predaja_.pdf

    Source Title

    Slovakia ŠÚKL MP 148/2025: free-sale certificate procedure and fee

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    sk-manufacturer-ecrep-registration

    Item

    Registration of an SR-seated manufacturer/EC representative

    Currency

    EUR

    Amount Local

    750

    Amount Local Formatted

    EUR 750

    Frequency

    Per registration

    Notes

    Per the ŠÚKL Sadzobník výkonov a služieb (service price list), invoiced after the service; payment is a condition of registration and non-refundable on refusal.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/registracia-zdravotnickej-pomocky-zp-od-vyrobcu-ec-rep-so-sidlom-v-sr/registracia-vyrobcu-a-zp

    Source Title

    Slovakia ŠÚKL: registration of a device by an SR manufacturer or EC representative (fee paragraphs)

    Verified On

    2026-08-25

  • Id

    additional-device-technical-assessment

    Item

    Technical-documentation assessment of each additional device under the same registration

    Currency

    EUR

    Amount Local

    430

    Amount Local Formatted

    EUR 430

    Frequency

    Per additional device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/registracia-zdravotnickej-pomocky-zp-od-vyrobcu-ec-rep-so-sidlom-v-sr/registracia-vyrobcu-a-zp

    Source Title

    Slovakia ŠÚKL: registration of a device by an SR manufacturer or EC representative (fee paragraphs)

    Verified On

    2026-08-25

Notes
  • Administrative fees follow the schedule annexed to zákon č. 145/1995 Z. z. as amended; SR-seated manufacturer registrations follow the separate ŠÚKL service price list.
  • Separate service-list fees also apply to device notification filings, change reports, and ŠÚKL code creation/update.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Slovakia ŠÚKL eKolok: administrative-fee table for devices

    Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok

    Accessed Date

    2026-08-25

  • Title

    Slovakia ŠÚKL MP 148/2025: free-sale certificate procedure and fee

    Url

    https://www.sukl.sk/buxus/docs/MP_148-2025_Postup_pri_podani_ziadosti_o_vystavenie_Certifikatu_volneho_predaja_.pdf

    Effective Date

    2025-01-01

    Accessed Date

    2026-08-25

  • Title

    Slovakia ŠÚKL: registration of a device by an SR manufacturer or EC representative (fee paragraphs)

    Url

    https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/registracia-zdravotnickej-pomocky-zp-od-vyrobcu-ec-rep-so-sidlom-v-sr/registracia-vyrobcu-a-zp

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

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

slovakia

Market

Slovakia

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

    nv-193-2016-radio-conformity

    Name

    Nariadenie vlády 193/2016 radio equipment conformity

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    §1(1) of nariadenie vlády 193/2016 Z. z. sets out the essential requirements for radio equipment as a designated product, the conformity-assessment procedures, the duties of manufacturer, authorised representative, importer and distributor, and the authorisation and notification of conformity-assessment bodies. Nothing in the decree creates a Slovak approval or homologation. The decree names only a generic orgán dohľadu — for instance §19(4), letting it require a test by a body acceptable to it — and leaves the designation to act 56/2018 Z. z., which was not read, so the identity of the surveillance body is not established here. The version read is effective to 27 December 2024 and a later consolidation exists.

    Source Urls
    • https://www.slov-lex.sk/static/pdf/2016/193/ZZ_2016_193_20191101.pdf
    Source Binding

    reviewed

  • Id

    zakon-346-2013-rohs-substance-restriction

    Name

    Act 346/2013 substance restriction (RoHS)

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    §1 of zákon 346/2013 Z. z., in its version effective 1 January 2026, sets the rules restricting certain hazardous substances in electrical and electronic equipment that is a designated product, the duties of manufacturer, authorised representative, importer and distributor, and the supervision and penalties; the technical requirements sit in vyhláška MŽP SR 465/2013 Z. z. 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.slov-lex.sk/static/pdf/2013/346/ZZ_2013_346_20260101.pdf
    Source Binding

    candidate

  • Id

    register-vyrobcov-vyhradeneho-vyrobku-bar

    Name

    Register výrobcov vyhradeného výrobku as a market bar

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Producer Or Authorised Representative

    Note

    Slovakia states the bar as plainly as any Member State. §30(1) of zákon 79/2015 Z. z. requires a producer of a designated product to apply for entry in the Register výrobcov vyhradeného výrobku before placing the product on the Slovak market, and adds that a producer not entered in the register may not place products on the Slovak market at all. §30(5) gives the ministry ten working days to make the entry and §30(10) makes the register publicly accessible. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.

    Source Urls
    • https://www.slov-lex.sk/static/pdf/2015/79/ZZ_2015_79_20260101.pdf
    Source Binding

    reviewed

  • Id

    register-vyrobcov-batteries-coverage

    Name

    Battery producers in the same designated-product register

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Battery Producer Or Authorised Representative

    Note

    Battery producers are producers of a designated product and use the same register, so the §30(1) market bar applies to them; §30(3) requires a battery producer discharging its duties through a third party to attach the contract confirmation to its application. A full-text search of the 1 January 2026 consolidation of zákon 79/2015 Z. z. for '2023/1542' returned nothing, so the Slovak waste act does not yet reference the Batteries Regulation, and whether Slovakia has adopted a separate implementing act or designated this register under Article 55 could not be checked because the Slov-Lex search interface is JavaScript-only. 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.slov-lex.sk/static/pdf/2015/79/ZZ_2015_79_20260101.pdf
    Source Binding

    candidate

  • Id

    uvz-radiation-source-supply-and-service-authorisation

    Name

    ÚVZ SR authorisation for radiation source supply and service

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Source Supply Service Or Import

    Note

    Act No. 87/2018 Z. z. on radiation protection § 28(6) requires an authorisation from the Public Health Authority for distributing, selling and renting an ionising radiation source whose use itself needs notification, registration or authorisation, and for importing a source from third countries. § 28(2) adds authorisation for manufacturing radiation sources or technology that incorporates them (a), for adding radionuclides or radioactive substances to consumer products, medicines and medical devices and importing or exporting such products (e), for testing radiation sources (f), and for installing, maintaining and repairing radiation sources except service on generators that does not expose persons (g). § 28(4) covers radiology, radiation oncology and nuclear medicine use, and § 28(8) applies the duty even to undertakings established in another Member State that already hold an equivalent authorisation there.

    Source Urls
    • https://static.slov-lex.sk/pdf/SK/ZZ/2018/87/ZZ_2018_87_20230415.pdf
    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

    Slov-Lex (Zbierka zákonov)

    Topic

    Nariadenie vlády 193/2016 Z. z. § 1 — radio equipment conformity framework

    Url

    https://www.slov-lex.sk/static/pdf/2016/193/ZZ_2016_193_20191101.pdf

  • Authority

    Slov-Lex (Zbierka zákonov)

    Topic

    Zákon 346/2013 Z. z. § 1 — RoHS restriction, duties and supervision

    Url

    https://www.slov-lex.sk/static/pdf/2013/346/ZZ_2013_346_20260101.pdf

  • Authority

    Slov-Lex (Zbierka zákonov)

    Topic

    Zákon 79/2015 Z. z. § 30 — register of designated-product producers and the bar on unregistered market placement

    Url

    https://www.slov-lex.sk/static/pdf/2015/79/ZZ_2015_79_20260101.pdf

  • Authority

    Slov-Lex (Zbierka zákonov Slovenskej republiky)

    Topic

    Act 87/2018 Z. z. — radiation source authorisation, distribution and import duties

    Url

    https://static.slov-lex.sk/pdf/SK/ZZ/2018/87/ZZ_2018_87_20230415.pdf

Keep researching this market

More Slovakia medical device resources

View the Slovakia resource hub →
Continue with this market
DJ Fang
Need to apply Slovakia's requirements to a product?
Confirm the current ŠÚKL pathway, evidence, and local-role details for the actual device before filing.
Pricing