Röntgeneinrichtungen und Störstrahler; Beantragung einer Genehmigung für den Betrieb bzw. Anzeige des Betriebs

X-ray equipment is generally subject to approval if it is not subject to notification due to the following exceptions:

• an X-ray source that is approved according to its design.
• an X-ray device that has a CE marking in accordance with the Medical Devices Act or Regulation (EU) 2017/745 (the former only applies if it was first placed on the market before May 26, 2021).

X-ray equipment for the following applications is exempt from this (i.e. requires approval)

• in technical radiography for coarse structural analysis in materials testing
• for the treatment (= therapeutic irradiation) of humans
• for teleradiology
• in connection with early detection
• mobile use (with the exception of (veterinary) medical emergencies)
• Temporary operation in an external X-ray room (demonstration operation)
• Operation in a mobile X-ray room (e.g. trailer)

A special case are the type-approved basic, high and full protection devices as well as school X-ray equipment, which are always subject to notification regardless of the type of application.

Radiation sources are always subject to approval unless they can be operated without approval on the basis of an exemption in accordance with Annex 3, Part D of the Radiation Protection Ordinance. There is no notification procedure for interference sources. Significant changes to operation must be treated in the same way as commissioning (notification, permit application).

The trade supervisory authority or the State Office for the Environment (only X-ray hybrid devices) will issue the permit or accept the notification upon your application.

• Printout of the appointment of radiation protection officers
• Evidence of professional competence
• Type approval certificate and/or test report of the expert
• if applicable, licence to practise medicine, cooperation agreement with medical physics experts, proof of sufficient personnel

• The application or notification must be submitted.
• The applicant must be reliable.
• A radiation protection officer must have been appointed.
• Sufficient persons with the necessary expertise in radiation protection or with the necessary knowledge of radiation protection are available.
• The equipment and radiation protection measures must correspond to the state of the art (test report by an expert, type approval if applicable, CE marking in accordance with Regulation (EU) 2017/745 or MPG).
• The activity must always be justified.
• Other public law regulations must not conflict with this.
• There are further requirements for the medical sector, e.g. submission of a license to practice medicine, radiation exposure indicator, consultation of a medical physics expert.

The costs for a permit are between EUR 75.00 and EUR 500.00 per device.
The notification procedure is free of charge.

Submit the documents to the trade supervisory office of the administrative district in which you have your business address (or place of residence). To ensure that your application is processed as quickly as possible, we recommend that you use the relevant online procedures, if available.

In the case of X-ray hybrid devices, the documents must be sent (in writing) to the State Office for the Environment.

The X-ray equipment may be put into operation at the earliest four weeks after notification to the responsible trade supervisory office. Operation at an earlier date is only permitted if the office issues the operating permit as part of a notification confirmation.

In the approval procedure, the X-ray equipment or the interference source may only be put into operation after the approval has been granted.