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Does my medical device need Pravilnik o radijski opremi in Slovenia?

Describe your device to check whether Pravilnik o radijski opremi 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 Pravilnik o radijski opremi check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.

Requirement family: Radio and spectrum approval
Regulatory object: radio equipment
Maintained rule status: mandatory if feature
Useful product facts: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

Article 1(1) of the pravilnik published at Uradni list RS 3/2016 sets the requirements for making radio equipment available on the market and putting it into service in accordance with Directive 2014/53/EU, issued under the technical requirements and conformity assessment act ZTZPUS-1. No national type approval appears in it. AKOS does adopt a national frequency use plan setting Slovenian spectrum conditions, which is a spectrum instrument rather than a product approval. Only the opening articles were read and later amendments were not checked; the competent surveillance body is not established from this text.

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.

Environmental / battery

Evidenca proizvajalcev registration

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

Radiation

Radiation practice licence and source-use licence

Applies to the facility, operator, or installation rather than only the product.

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

Pravilnik o radijski opremi (UL RS 3/2016) 1. člen — RED scope

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.