X-ray equipment is generally subject to approval unless it is subject to notification due to the following exceptions:
- - an X-ray source which is approved by 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).
Exempt from this in turn (i.e. subject to approval) are X-ray devices for the following applications:
- - in technical radiography for coarse structure 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 a foreign X-ray room (demonstration operation)
- - operation in a mobile X-ray room (e.g. trailer)
A special case is formed by the type-approved basic, high and full protection devices as well as school X-ray facilities, which are always subject to notification regardless of the type of use.
Interference sources are always subject to approval, unless they can be operated without approval due to an exception according to Annex 3, Part D of the Radiation Protection Ordinance. A notification procedure is not provided for interference sources. Significant changes in operation must be treated in the same way as commissioning (notification, application for approval).
The Trade Inspectorate or the State Office for the Environment (only X-ray hybrid devices) issues the license upon your application or accepts the notification.