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Does my medical device need SSM licence or notification for ionising radiation activity in Sweden?

Describe your device to check whether SSM licence or notification for ionising radiation activity 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 SSM licence or notification for ionising radiation activity 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: ionising radiation activity or equipment supply
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Strålskyddslagen (2018:396) 6 kap. 1 § prohibits conducting an activity with ionising radiation without a licence; 6 kap. 6 § allows that licence duty to be replaced by a notification duty where radiation protection permits; and 6 kap. 8 § empowers the government or the appointed authority to require notification of the acquisition, holding, transfer, letting, offering for sale or import into Sweden of technical devices capable of generating ionising radiation, and of handling components of material radiation-protection significance manufactured for such devices. Strålskyddsförordningen (2018:506) 5 kap. 1 § makes Strålsäkerhetsmyndigheten the deciding authority, 5 kap. 4 § carries the notification power for sale and import, and 5 kap. 5 a § lists the licence application content including the source inventory, the radiation protection expert function and the end-of-activity source disposal plan.

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 Sweden routes to check

Check every Sweden 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

Radioutrustningslagen market access

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

Environmental / battery

Förordning 2012:861 substance restriction (RoHS)

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

Environmental / battery

Naturvårdsverket producer notification and register

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

Environmental / battery

Battery producer register and prior approval

Maintained as a mandatory pre-market route.

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.

Sveriges riksdag

strålskyddslagen (2018:396) chapter 6 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 Sweden 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 Sweden?: 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.