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Does my medical device need Radioudstyrsloven market access in Denmark?

Describe your device to check whether Radioudstyrsloven market access 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 Radioudstyrsloven market access 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.

LBK nr 958 of 22 June 2022, implemented by bekendtgørelse nr. 1107 of 6 November 2019, conditions placing radio equipment on the market on conformity with the essential requirements in §17, conformity assessment and CE marking under §18, with §18(1) also requiring that the equipment can be used in at least one Member State without breaching spectrum rules. §32 makes Sikkerhedsstyrelsen the control authority, while Digitaliseringsstyrelsen supervises use. The act contains no free-movement article, so the absence of a Danish type approval rests on a full read of the act finding no such provision rather than on an express negative.

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 Denmark routes to check

Check every Denmark 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

Bekendtgørelse 1369/2024 substance restriction (RoHS)

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

Environmental / battery

Producentregistret registration 14 days before first supply

Maintained as a mandatory pre-market route.

Environmental / battery

Battery producer register under the Batteries Regulation

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

Radiation

Sundhedsstyrelsen radiation generator licence

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.

The maintained country source registry does not yet map a direct authority page to this exact route. The checker will not substitute an unrelated source. Confirm the current scope with the responsible authority before relying on the result.

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 Denmark 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 Denmark?: 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.