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Does my medical device need Sundhedsstyrelsen radiation generator licence in Denmark?

Describe your device to check whether Sundhedsstyrelsen radiation generator licence 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 Sundhedsstyrelsen radiation generator licence check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: radiation generator supply service or use site
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Bekendtgørelse nr. 671 af 1. juli 2019 om brug af strålingsgeneratorer § 4 makes a Sundhedsstyrelsen tilladelse mandatory not only for using radiation generators but for manufacturing them, for modifications including cleaning, maintenance and repair that can affect radiation protection or that set a medical generator to service mode, for installing medical and veterinary radiation generators, for acceptance and status testing, and for periodic inspection. § 5 replaces the licence with a notification for the annex 1 uses, § 6 exempts inspection where the inspecting company already holds the licence for the generator, and § 7 requires the licence or notification before use begins. It supplements bekendtgørelse nr. 669 af 1. juli 2019.

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.

Wireless / radio

Radioudstyrsloven market access

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

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.

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.

Sundhedsstyrelsen

BEK nr 671 of 2019 on the use of radiation generators — licence and notification duties

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.