X-ray equipment and interfering radiators; application for a permit to operate or notification of operation.

You must usually apply for a permit or report it in order to operate an X-ray facility or an interference source.

Description

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.

Prerequisites

  • The application or notification must be available.
  • The applicant must be reliable.
  • A radiation protection officer must have been appointed.
  • Sufficient persons with the required expertise in radiation protection or with the required knowledge in radiation protection are available.
  • The equipment and measures for radiation protection must correspond to the state of the art (test report by an expert, type approval if necessary, CE marking according to Regulation (EU) 2017/745 or MPG).
  • The activity must be justified in principle.
  • Other regulations under public law must not conflict with this.
  • For the medical field, there are further requirements such as presentation of the license to practice medicine, display instrument for radiation exposure, consultation of a medical physics expert.

Procedure

Submit the documents to the trade supervisory office of the administrative district in which you have your business address (residence, if applicable). For the fastest possible processing of your application, the use of the corresponding online procedures is recommended - if available.

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

Deadlines

The X-ray equipment may be put into operation no earlier than four weeks after notification to the responsible trade supervisory office. Operation at an earlier point in time is only permissible 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.

Required documents

  • 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

Forms

Please select a location in "Localization" so that the address of the responsible authority can be filled in.

Online procedures

Fees

  • The cost of a permit ranges from EUR 75.00 to EUR 500.00 per device.
    The notification procedure is free of charge.

Status:30.08.2023

Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

Contains machine translated content. Show the original content

  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
Bild zur Leistungsbeschreibung

Responsible for you

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.