Free · No signup · Official source links

Does my medical device need OUG 5/2015 national WEEE producer register as a condition of placing on the market in Romania?

Describe your device to check whether OUG 5/2015 national WEEE producer register as a condition of placing on the market 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 OUG 5/2015 national WEEE producer register as a condition of placing on the market check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Maintained as a mandatory pre-market route.

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

ORDONANȚĂ DE URGENȚĂ nr. 5 of 2 April 2015, Monitorul Oficial nr. 253 of 16 April 2015. Article 38(1) has the Agenția Națională pentru Protecția Mediului keep a national producer register that includes distance sellers. Article 38(2) is the gate: in order to place EEE on the market, producers must enrol in that register and receive a registration number which they then communicate to every commercial network through which the equipment is sold. Distance sellers into Romania who are not themselves registered enrol through an authorised representative under article 38(4) and article 40(2). Medical devices are inside the open scope: Annex 1 category 8 is dispozitive medicale, with the usual exclusion of implanted and infective products, and article 5(g) repeats the Directive 2012/19/EU exclusion for devices expected to be infective before end of life and for active implantable devices. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.

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

HG 1.132/2008 battery producer register, not yet adapted to Regulation (EU) 2023/1542

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.

EUR-Lex

WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national 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.