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 445/2012. (XII. 29.) Korm. rendelet implementing the Batteries Regulation in Hungary?
Describe your device to check whether 445/2012. (XII. 29.) Korm. rendelet implementing the Batteries Regulation may apply, why, what facts are missing, and which official source to review.
9 maintained routes12 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 445/2012. (XII. 29.) Korm. rendelet implementing the Batteries Regulation 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.
- Requirement family
- Environmental and battery obligations
- Regulatory object
- battery 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.
Worth contrasting with neighbours that have not moved: the Hungarian battery decree, consolidated to 18 August 2026, has already been rebuilt around Regulation (EU) 2023/1542 rather than left on the repealed Directive 2006/66/EC. 2. § (2) makes the Regulation's definitions directly applicable inside the decree, 5. § (2) sets the collection duty by reference to Articles 59(3) and 60(3) of the Regulation, 14. § sets the producer's record-keeping content by reference to Article 75, 24/A. § designates the országos hulladékgazdálkodási hatóság as the control and competent authority for Article 69(2)–(5), and 30. § (1a) states in terms that the decree lays down the provisions needed to implement the Regulation. 15. § (1) requires the annual data return to that authority by 20 February following the reference year. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
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 Hungary 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
2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties
Applies when the product, feature, component, or use is in scope.
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.
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.
Environmental / battery
80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration
Applies when the product, feature, component, or use is in scope.
Environmental / battery
Környezetvédelmi termékdíj, which no longer reaches electrical equipment or batteries
Applies when the product, feature, component, or use is in scope.
Radiation
Chief Medical Officer radiation opinion for clinical investigations
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 Hungary 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 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
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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