Explore the IVD requirements currently available for Slovakia, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What expires, what is retained periodically, and when must renewal start?
A 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.
Effective from 2021-05-26
Fee 500 € (450 € for fully electronic filing) per registration period.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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).
Sadzobník fees are invoiced after the service is performed.
Which clinical or IVD performance evidence or study is required and accepted?
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.
Ministry of Health statement on the ethics committee procedure is linked by ŠÚKL.
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.
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.'
Which evidence, local deltas, formats, and signatures are required?
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.
Labelling may alternatively use symbols per EN ISO 15223-1 / EN 980; CE mark min. vertical dimension 5 mm.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
Power of attorney accepted in Slovak, officially translated into Slovak, or multilingual with Slovak binding text.
Which establishment licences, importer permissions, and distribution controls apply?
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).
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.
What regulator fee applies to this class, route, event, and date?
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.
eKolok mechanism applies to all section-ZP administrative fees; paying to ŠÚKL's account directly is treated as an invalid payment.
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.
Fee rule the fee dataset cannot express; amounts recorded in typedFindings.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
Key national delta over MDR Art. 10(11): Slovakia actually requires Slovak, via § 110b ods. 1.
Which current law, regulation, guidance, and transition provisions apply?
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. 166/2020 Z. z. (medical devices, Directive 93/42/EHS), NV č. 167/2020 Z. z. (active implantable devices) and NV č. 569/2001 Z. z. (IVDs, Directive 98/79/ES).
ŠÚKL notification page references the NV annexes as the labelling/IFU standard for legacy devices.
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 IVD manufacturers/EC reps seated in SR, § 110a distributor registration, § 110b notification duty incl. Slovak-language label/IFU (ods. 1) and 14-day notification (ods. 2), § 129 ods. 2 písm. aj) free-sale certificates.
Law of record on slov-lex.sk; the individual §§ were verified on official ŠÚKL pages that cite them (FAQ, procedure pages, MP 148/2025). The brief's hypotheses (zákon 364/2012, zákon 132/2023) are incorrect — no such device laws exist.
Which current form, portal, account, and submission package must be used?
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.
eKolok payment order per MP 148/2025: 'platobný predpis vygenerovaný v systéme eKolok pre toto konkrétne podanie'.
Which recall, FSCA, notice, and authority-coordination duties apply?
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).
FSCA/FSN notification duties as such follow MDR/IVDR; the national delta is the ŠÚKL system and national FSN forms.
Which registration, notification, listing, reliance, or conformity route applies?
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.
Effective from 2026-05-28
Fee form TL SZP 037 (Návrh na vyúčtovanie) still required among documents.
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 €.
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.
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.
Upgrades the r187 baseline (which cited EUR-Lex) to ŠÚKL national sources.
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.
Notification is therefore an information duty, not a pre-market approval.
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.
Deadline restated by ŠÚKL in its 28.5.2026 EUDAMED transition notice.
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).
ŠÚKL assigns a national code (ŠÚKL kód) upon completed notification.
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).
ŠÚKL checks completeness of technical documentation during registration.
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
slovakia
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
Proceedings run under the Administrative Procedure Code (zákon č. 71/1967 Zb.), which ŠÚKL cites including § 30(1)(d) on discontinuation.
Which UDI, device listing, database, and traceability duties apply?
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).
Code assignment is charged per the Sadzobník výkonov a služieb ŠÚKL.
What is reportable, by whom, where, in what format, and by what deadline?
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.
National reporting channel and national form TL SZP 075 are the Slovak delta on top of MDR/IVDR vigilance.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Slovakia
slovakia
SK
🇸🇰
State Institute for Drug Control
ŠÚKL
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by ŠÚKL. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to ŠÚKL including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
ŠÚKL reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. ŠÚKL may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, ŠÚKL issues Slovakia market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
slovakia
Slovakia
SK
ŠÚKL
300
300
EUR
No
750
750
EUR
No
distributor-registration
Distributor registration decision (item 96.1.56)
EUR
500
EUR 500
Per registration
EUR 450 when the filing is fully electronic. Paid via eKolok within 30 days.
exact-current
official-verified
https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok
Slovakia ŠÚKL eKolok: administrative-fee table for devices
2026-08-25
clinical-investigation-authorisation
Clinical-investigation authorisation proceedings (item 96.1.57)
EUR
500
EUR 500
Per application
Not refunded on rejection.
exact-current
official-verified
https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok
Slovakia ŠÚKL eKolok: administrative-fee table for devices
2026-08-25
ci-substantial-change-notification
Notification of substantial change to a clinical investigation (item 96.1.58)
EUR
500
EUR 500
Per notification
exact-current
official-verified
https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok
Slovakia ŠÚKL eKolok: administrative-fee table for devices
2026-08-25
ci-notification-ce-device
Notification of a clinical investigation of a CE-marked device (item 96.1.59)
EUR
500
EUR 500
Per notification
exact-current
official-verified
https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok
Slovakia ŠÚKL eKolok: administrative-fee table for devices
2026-08-25
free-sale-certificate
Free-sale certificate for devices and IVDs (item 152 aj)
EUR
300
EUR 300
Per certificate
Paid via eKolok payment order per filing, not in advance (MP 148/2025).
exact-current
official-verified
https://www.sukl.sk/buxus/docs/MP_148-2025_Postup_pri_podani_ziadosti_o_vystavenie_Certifikatu_volneho_predaja_.pdf
Slovakia ŠÚKL MP 148/2025: free-sale certificate procedure and fee
2025-01-01
2026-08-25
sk-manufacturer-ecrep-registration
Registration of an SR-seated manufacturer/EC representative
EUR
750
EUR 750
Per registration
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.
exact-current
official-verified
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
Slovakia ŠÚKL: registration of a device by an SR manufacturer or EC representative (fee paragraphs)
2026-08-25
additional-device-technical-assessment
Technical-documentation assessment of each additional device under the same registration
EUR
430
EUR 430
Per additional device
exact-current
official-verified
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
Slovakia ŠÚKL: registration of a device by an SR manufacturer or EC representative (fee paragraphs)
2026-08-25
2026-08-25
official-verified
Slovakia ŠÚKL eKolok: administrative-fee table for devices
https://www.sukl.sk/pre-odbornikov-a-firmy/zdravotnicke-pomocky/postupy-pri-podavani-ziadosti/uhrada-spravnych-poplatkov-cez-ekolok
2026-08-25
Slovakia ŠÚKL MP 148/2025: free-sale certificate procedure and fee
https://www.sukl.sk/buxus/docs/MP_148-2025_Postup_pri_podani_ziadosti_o_vystavenie_Certifikatu_volneho_predaja_.pdf
2025-01-01
2026-08-25
Slovakia ŠÚKL: registration of a device by an SR manufacturer or EC representative (fee paragraphs)
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
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
slovakia
Slovakia
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
candidate
nv-193-2016-radio-conformity
Nariadenie vlády 193/2016 radio equipment conformity
Radio Spectrum
Mandatory If Feature
Radio Equipment
§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.
reviewed
zakon-346-2013-rohs-substance-restriction
Act 346/2013 substance restriction (RoHS)
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
§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.
candidate
register-vyrobcov-vyhradeneho-vyrobku-bar
Register výrobcov vyhradeného výrobku as a market bar
Environmental And Batteries
Mandatory Pre Market
Producer Or Authorised Representative
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.
reviewed
register-vyrobcov-batteries-coverage
Battery producers in the same designated-product register
Environmental And Batteries
Mandatory Pre Market
Battery Producer Or Authorised Representative
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.
candidate
uvz-radiation-source-supply-and-service-authorisation
ÚVZ SR authorisation for radiation source supply and service
Ionizing Radiation
Mandatory If Feature
Radiation Source Supply Service Or Import
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.
reviewed
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Slov-Lex (Zbierka zákonov)
Nariadenie vlády 193/2016 Z. z. § 1 — radio equipment conformity framework
https://www.slov-lex.sk/static/pdf/2016/193/ZZ_2016_193_20191101.pdf
Slov-Lex (Zbierka zákonov)
Zákon 346/2013 Z. z. § 1 — RoHS restriction, duties and supervision
https://www.slov-lex.sk/static/pdf/2013/346/ZZ_2013_346_20260101.pdf
Slov-Lex (Zbierka zákonov)
Zákon 79/2015 Z. z. § 30 — register of designated-product producers and the bar on unregistered market placement
https://www.slov-lex.sk/static/pdf/2015/79/ZZ_2015_79_20260101.pdf
Slov-Lex (Zbierka zákonov Slovenskej republiky)
Act 87/2018 Z. z. — radiation source authorisation, distribution and import duties
https://static.slov-lex.sk/pdf/SK/ZZ/2018/87/ZZ_2018_87_20230415.pdf
