Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need StrlSchG licence or notification for operating X-ray equipment in Germany?
Describe your device to check whether StrlSchG licence or notification for operating X-ray equipment may apply, why, what facts are missing, and which official source to review.
10 maintained routes13 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 StrlSchG licence or notification for operating X-ray equipment check is screening
Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.
- Requirement family
- Ionizing radiation and radioactive sources
- Regulatory object
- x ray installation operator
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
StrlSchG § 12(1) makes operating a radiation generator, handling radioactive substances, operating an X-ray installation and operating an interference emitter licence-liable. § 19(1) reduces the duty to a notification for X-ray equipment whose emitter is design-approved under § 45(1) no. 2 or that was placed on the market under Regulation (EU) 2017/745 or the former Medizinproduktegesetz, and § 19(2) restores the licence duty in the listed cases. The obligation attaches to the operator of the installation, not to placing the device on the market.
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.
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 Germany routes to check
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
Funkanlagengesetz (RED) conformity
Applies when the product, feature, component, or use is in scope.
Environmental / battery
ElektroStoffV substance restriction (RoHS)
Evidence may be required, but the matrix does not identify a generic separate certificate.
Environmental / battery
ElektroG producer registration with stiftung ear
Maintained as a mandatory pre-market route.
Environmental / battery
BattDG battery producer registration
Applies when the product, feature, component, or use is in scope.
Metrology
MPBetreibV metrological controls
Applies to the facility, operator, or installation rather than only the product.
Electrical safety
MPBetreibV safety-technical controls
Applies to the facility, operator, or installation rather than only the product.
Product-specific
BfArM DiGA listing per DiGAV
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.
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 Germany 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 Germany?
- 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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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