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Does my medical device need HG 1.132/2008 battery producer register, not yet adapted to Regulation (EU) 2023/1542 in Romania?

Describe your device to check whether HG 1.132/2008 battery producer register, not yet adapted to Regulation (EU) 2023/1542 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 HG 1.132/2008 battery producer register, not yet adapted to Regulation (EU) 2023/1542 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.

HOTĂRÂRE nr. 1.132 of 18 September 2008, in the form last amended by HG 540/2016. Article 6(3) allows batteries and accumulators to be placed on the market only by producers entered in the Registrul național al producătorilor și importatorilor de baterii și acumulatori, kept by the environment ministry through the Agenția Națională pentru Protecția Mediului, and article 6(4) points the enrolment procedure to Annex 4. A full-text search of that consolidated expression contains no occurrence of '2023/1542', so the national decision still sits on the repealed Directive 2006/66/EC and no Article 55 designation appears in it; the Regulation applies directly in the meantime, which is the same split already recorded for Bulgaria and the Czech Republic and the opposite of Slovenia. 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.

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 Romania routes to check

Check every Romania 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.

Wireless / radio

HG 740/2016 radio equipment market access

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

Electrical safety

ANMDMR in-use verification tests

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

Environmental / battery

HG 322/2013 restricting hazardous substances in electrical equipment

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

Environmental / battery

OUG 5/2015 national WEEE producer register as a condition of placing on the market

Maintained as a mandatory pre-market route.

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.

EUR-Lex

Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register

Portal Legislativ (legislatie.just.ro)

HG 1.132/2008 as amended by HG 540/2016 — article 6(3)–(4) battery producer register

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 Romania 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 Romania?: 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.