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 MDR electrical safety in place of the Low Voltage Directive in Hungary?
Describe your device to check whether MDR electrical safety in place of the Low Voltage Directive may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 candidate 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 MDR electrical safety in place of the Low Voltage Directive check is screening
Checks whether electrical safety is dossier evidence or a separate national product certificate. Evidence is normally handled inside the medical-device registration route.
Source association awaiting review. These are unreviewed candidate links retained from legacy data. They must not be cited as proof that this route or requirement applies.
- Requirement family
- Medical electrical safety
- Regulatory object
- finished device
- Maintained rule status
- included in medical registration
- Useful product facts
- Power source, voltage, intended environment, patient connection, device type, and IEC/CB evidence.
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
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
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
80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration
Applies when the product, feature, component, or use is in scope.
Source association reviewed
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
Candidate sources awaiting review
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
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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