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Does my medical device need Radiation practice licence and source-use licence in Slovenia?

Describe your device to check whether Radiation practice licence and source-use licence may apply, why, what facts are missing, and which official source to review.

7 maintained routes11 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 Radiation practice licence and source-use licence check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.

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

Uredba o sevalnih dejavnostih (Uradni list RS 19/2018), issued under ZVISJV-1, art. 12 requires a licence to carry out a radiation practice for, among others, using X-ray devices, radiation sources and particle accelerators other than electron microscopes, intentionally adding radioactive substances when producing consumer goods or medicines and importing or exporting such items, and administering radioactive substances to persons for medical purposes. Art. 16 layers a separate source-use licence on high-activity sealed sources, X-ray devices operating above 160 kV where the radiation protection assessment rates the risk as high, particle accelerators and open sources above the exemption level; other sources must be entered in the register of radiation sources before use, and the licence application must already include the valid radiation practice licence.

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 Slovenia routes to check

Check every Slovenia 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

Pravilnik o radijski opremi

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

Environmental / battery

Evidenca proizvajalcev registration

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

Environmental / battery

Pravilnik o omejevanju uporabe določenih nevarnih snovi v EEO

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

Environmental / battery

Uredba o izvajanju Uredbe (EU) o baterijah in odpadnih baterijah

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

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.

Uradni list Republike Slovenije

Uredba o sevalnih dejavnostih — radiation practice and source-use licences

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 Slovenia 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 Slovenia?: 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.