Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need Pravilnik o omejevanju uporabe določenih nevarnih snovi v EEO in Slovenia?
Describe your device to check whether Pravilnik o omejevanju uporabe določenih nevarnih snovi v EEO 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 omejevanju uporabe določenih nevarnih snovi v EEO check is screening
Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Evidence may be required, but the matrix does not identify a generic separate certificate.
- Requirement family
- Environmental and battery obligations
- Regulatory object
- electrical electronic medical device
- Maintained rule status
- evidence only no separate certificate
- Useful product facts
- Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.
Read from the as-enacted text in Uradni list RS 102/2012 (sop 2012-01-3952), issued by the minister of health under article 5 of the act on technical requirements for products. Article 2 applies the pravilnik to the Annex I categories of Directive 2011/65/EU and excludes active implantable medical devices. Article 4 (pogoji za dajanje na trg) forbids placing on the Slovenian market electrical and electronic equipment, cables and repair, reuse, upgrade or capacity-increase spare parts containing the Annex II substances above the concentration limits in homogeneous materials; the same article then carves out medical devices placed on the market before 22 July 2014 and in vitro diagnostic medical devices placed on the market before 22 July 2016, which is the national restatement of the Union dates rather than a Slovenian delay. There is no separate Slovenian RoHS certificate: conformity is shown by the EU declaration and CE marking under the internal-production-control procedure in the following articles. Later amendments (including UL RS 60/2016) exist; this row is sourced to the 2012 enactment that still carries the medical-device dates and the active-implantable exclusion. 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.
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.
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
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.
Radiation
Radiation practice licence and source-use licence
Applies to the facility, operator, or installation rather than only the product.
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.
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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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