Free · No signup · Official source links

Does my medical device need Règlement grand-ducal du 30 juillet 2013 substance restriction (RoHS) in Luxembourg?

Describe your device to check whether Règlement grand-ducal du 30 juillet 2013 substance restriction (RoHS) may apply, why, what facts are missing, and which official source to review.

8 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 Règlement grand-ducal du 30 juillet 2013 substance restriction (RoHS) 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.

Article 3(1) and (2) of the règlement grand-ducal modifié of 30 July 2013 provide that EEE placed on the market, including cables and spare parts for repair, reuse, functional updating or capacity upgrading, contain none of the Annex II substances above the maximum concentration by weight in homogeneous materials. The coordinated text read is consolidated to 24 March 2014, so its annexes are superseded by later règlements even though article 3 is stable, and the instrument as read designates no market surveillance authority. 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 Luxembourg routes to check

Check every Luxembourg 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

Loi du 27 juin 2016 on making radio equipment available

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

Environmental / battery

Registre des producteurs for electrical and electronic equipment

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

Environmental / battery

Batteries Regulation producer register pending a national act

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

Radiation

Division de la radioprotection establishment authorisation

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

Radiation

Acceptance test and conformity finding before use

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.

Legilux

Règlement grand-ducal du 30 juillet 2013 art. 3 — RoHS substance limits (texte coordonné)

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 Luxembourg 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 Luxembourg?: 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.