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Does my medical device need HG 322/2013 restricting hazardous substances in electrical equipment in Romania?

Describe your device to check whether HG 322/2013 restricting hazardous substances in electrical equipment 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 322/2013 restricting hazardous substances in electrical equipment check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Evidence may be required, but the matrix does not identify a generic separate certificate.

Requirement family: Environmental and battery obligations
Regulatory object: electrical electronic medical device
Maintained rule status: evidence only no separate certificate
Useful product facts: Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.

HOTĂRÂRE nr. 322 of 29 May 2013, Monitorul Oficial nr. 348 of 13 June 2013, transposes Directive 2011/65/EU. Article 2(1) applies the decision to the Annex 1 categories, and Annex 1 category 8 is dispozitive medicale. Article 2(4)(h) (as numbered in the published text) keeps active implantable devices out. Article 4(3) is the date that matters for a device manufacturer: the substance restriction applies to medical devices and monitoring and control instruments placed on the market from 22 July 2014, to in vitro diagnostic medical devices from 22 July 2016 and to industrial monitoring and control instruments from 22 July 2017; article 4(4) then leaves devices placed on the market before those dates, and their repair spare parts, outside the restriction. There is no Romanian RoHS certificate sitting next to the CE marking. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.

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

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

Maintained as a mandatory pre-market route.

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

Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope

Portal Legislativ (legislatie.just.ro)

HG 322/2013 — articles 2 and 4 and Annex 1 category 8

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.