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Does my medical device need Arrêté royal du 25 mars 2016 radio equipment conformity in Belgium?

Describe your device to check whether Arrêté royal du 25 mars 2016 radio equipment conformity 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 25 mars 2016 radio equipment conformity check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.

Requirement family: Radio and spectrum approval
Regulatory object: radio equipment
Maintained rule status: mandatory if feature
Useful product facts: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

The arrêté royal of 25 March 2016 on making radio equipment available on the market states in article 1 that it transposes Directive 2014/53/EU, and its essential requirements refer back to article 32 of the loi of 13 June 2005 on electronic communications. IBPT/BIPT is the market surveillance and notifying authority and publishes that it checks the conformity of radio equipment made available on the Belgian market. The decree text carries no national type approval or homologation for placing on the market; a separate IBPT holding or use authorisation exists for certain categories of apparatus, which is a spectrum permission rather than a product approval.

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.

Environmental / battery

Arrêté royal du 17 mars 2013 substance restriction (RoHS)

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

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 25 mars 2016 relatif à la mise à disposition sur le marché d'équipements hertziens

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.