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Does my medical device need 80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration in Hungary?

Describe your device to check whether 80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration may apply, why, what facts are missing, and which official source to review.

1 maintained routes1 official source links
Preliminary applicability · country-specific scope

Check 80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration

Try an example

Include power, radio modules and bands, measurement functions, radiation or energy, batteries, materials, accessories, intended use, and existing test reports.

Preliminary decision support — not a regulator determination or legal advice.0 / 8,000
Market being checked
Hungary

Fair-use limits apply. Your input and result are not a regulator determination or legal advice.

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 80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Applies when the product, feature, component, or use is in scope.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family
Environmental and battery obligations
Regulatory object
producer or authorised representative
Maintained rule status
mandatory if feature
Useful product facts
Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.

This is the single registration gate for a device that is electrical equipment or contains batteries, and its timing is stricter than the neighbouring one-month regimes. 23. § (1) requires the producer to apply to the országos hulladékgazdálkodási hatóság for entry in the register before starting activity with the circular product, declaring whether extended producer responsibility will be met collectively or individually under 8. §. 6. § a) adds a first step before that application: the producer must supply the 3. melléklet point 1 data to the concession company on its electronic platform, which is why practitioners describe the Hungarian entry as a double registration. 23. § (9) gives the authority 15 days to register a conforming application, 23. § (3) lets it register a producer as a collective performer of its own motion where no individual declaration or valid concession contract is produced, and 23. § (8) closes the obvious gap by making the extended producer responsibility fee payable on quantities placed on the market before registration was completed.

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 Hungary routes to check

Check every Hungary route →
Electrical safety

MDR electrical safety in place of the Low Voltage Directive

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

Source association awaiting review

EMC

MDR electromagnetic compatibility in place of the EMC Directive

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

Source association awaiting review

Wireless / radio

2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties

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

Source association awaiting review

Environmental / battery

374/2012. (XII. 18.) Korm. rendelet restricting hazardous substances in electrical equipment

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

Source association awaiting review

Environmental / battery

197/2014. (VIII. 1.) Korm. rendelet on waste electrical and electronic equipment

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

Source association awaiting review

Environmental / battery

445/2012. (XII. 29.) Korm. rendelet implementing the Batteries Regulation

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

Source association awaiting review

Environmental / battery

Környezetvédelmi termékdíj, which no longer reaches electrical equipment or batteries

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

Source association awaiting review

Radiation

Chief Medical Officer radiation opinion for clinical investigations

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

Source association awaiting review

Reviewed source associations

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 Hungary scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.

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 Hungary?
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
DJ Fang
MedTech Regulatory Expert

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