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ŠÚKL · Europe

Slovakia medical device regulatory resources

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Medical device regulation news

Follow recent State Institute for Drug Control (ŠÚKL) policy, guidance, safety, and compliance updates.

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Government registration fees

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Slovakia 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 34 source-linked facts →

24 of 25 research dimensions currently covered · 22 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Competent authority
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 devic…
Medical Devices Section within ŠÚKL
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 inspe…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National implementation law
Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach (as amended, including zákon č. 293/2023 Z. z.) is the national law supplementing MDR/IVDR in Slovakia: § 110 registration of IV…
Legacy national regulations for pre-MDR devices
For devices placed on the Slovak market before 26 May 2021, the national government regulations implementing the old directives still govern national documentation expectations: NV č. 166/2…
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Device definition (MDR Art. 2(1))
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 b…
1 source-linked fact
Checked 2026-08-29
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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: 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 Š…
National notification of devices from manufacturers seated outside Slovakia
Manufacturers of medical devices (including active implantable devices) seated outside Slovakia — and their EC representatives, importers or distributors that make the device available on t…
8 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:svk · 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
Who may file the national notification
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 file…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Distributor registration (§ 110a) — voluntary now, mandatory from 28.5.2026
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 o…
1 source-linked fact
Checked 2026-08-25
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D09

Dossier requirements

Verified
National notification/registration dossier
The ŠÚKL notification/registration package comprises: (1) cover letter; (2) original power of attorney (Slovak, officially translated, or multilingual with Slovak text); (3) registration/no…
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
Filing channels and national forms
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 Z…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Slovak-language label and IFU requirement
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. Nationa…
1 source-linked fact
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
Nariadenie vlády 193/2016 radio equipment conformity
Wireless / radio
7 maintained overlays
Checked 2026-09-07
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D14

Fees

Verified
Distributor registration decision (item 96.1.56)
EUR 500
Clinical-investigation authorisation proceedings (item 96.1.57)
EUR 500
7 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
Distributor registration valid 5 years
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…
1 source-linked fact
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change notification to ŠÚKL
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 sa…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
ŠÚKL national device codes
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…
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
ŠÚKL permission for clinical investigations and IVD performance studies
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 invest…
Ethics committee opinion gates the authorisation
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 subm…
2 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
In-house health-institution exemption (Art. 5(5))
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…
1 source-linked fact
Checked 2026-08-29
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
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…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
Direct reporting of suspected serious incidents by professionals and patients
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…
1 source-linked fact
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
ŠÚKL vigilance system covers MIR and FSCA
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 use…
1 source-linked fact
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Misleading claims prohibition (Art. 7)
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…
1 source-linked fact
Checked 2026-08-29
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D25

Submission communications & appeal

Verified
Deficiency notices (výzvy) served electronically via slovensko.sk
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 person…
1 source-linked fact
Checked 2026-08-25
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Government fees

Full fee schedule (7 lines) →

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

Fee lineAmountProvenance
Distributor registration decision (item 96.1.56)EUR 500Verified
Clinical-investigation authorisation proceedings (item 96.1.57)EUR 500Verified
Notification of substantial change to a clinical investigation (item 96.1.58)EUR 500Verified
Notification of a clinical investigation of a CE-marked device (item 96.1.59)EUR 500Verified
3 more fee lines on the full schedule · 7 of 7 rows source-verified

Registration timeline

Full registration timeline →

State Institute for Drug Control (ŠÚKL) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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