Free · No signup · Official source links

Does my medical device need Arrêté royal du 17 mars 2013 substance restriction (RoHS) in Belgium?

Describe your device to check whether Arrêté royal du 17 mars 2013 substance restriction (RoHS) may apply, why, what facts are missing, and which official source to review.

7 maintained routes12 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 Arrêté royal du 17 mars 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 1 of the arrêté royal of 17 March 2013, last updated 24 December 2024, states that it transposes Directive 2011/65/EU, and its Chapter III carries the prohibition on placing non-compliant equipment on the market. The instrument issues from the SPF Santé publique, Sécurité de la Chaîne alimentaire et Environnement. 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 Belgium routes to check

Check every Belgium 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

Arrêté royal du 25 mars 2016 radio equipment conformity

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

Environmental / battery

Regional WEEE acceptance obligation and BeWeee reporting

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

Environmental / battery

Batteries Regulation producer responsibility through the Regions

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

Radiation

FANC/AFCN radiation establishment authorisation

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

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.

Justel (SPF Justice)

Arrêté royal du 17 mars 2013 limitant l'utilisation de certaines substances dangereuses (RoHS)

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 Belgium 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 Belgium?: 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.