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Does my medical device need ÚVZ SR authorisation for radiation source supply and service in Slovakia?

Describe your device to check whether ÚVZ SR authorisation for radiation source supply and service may apply, why, what facts are missing, and which official source to review.

7 maintained routes9 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this ÚVZ SR authorisation for radiation source supply and service check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: radiation source supply service or import
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

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.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Slovakia routes to check

Check every Slovakia route →

Electrical safety

MDR electrical safety in place of the Low Voltage Directive

Evidence is normally handled inside the medical-device registration route.

EMC

MDR electromagnetic compatibility in place of the EMC Directive

Evidence is normally handled inside the medical-device registration route.

Wireless / radio

Nariadenie vlády 193/2016 radio equipment conformity

Applies when the product, feature, component, or use is in scope.

Environmental / battery

Act 346/2013 substance restriction (RoHS)

Evidence may be required, but the matrix does not identify a generic separate certificate.

Environmental / battery

Register výrobcov vyhradeného výrobku as a market bar

Maintained as a mandatory pre-market route.

Environmental / battery

Battery producers in the same designated-product register

Maintained as a mandatory pre-market route.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

Slov-Lex (Zbierka zákonov Slovenskej republiky)

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

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Slovakia scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Slovakia?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.