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

As a rule, the operation of an X-ray facility or an interference source requires either a permit or notification.

Description

This depends on the type of device or its use. The trade supervisory authority or the State Office for the Environment will issue the permit or accept the notification upon your application.

The operation of X-ray equipment is subject to approval if it does not have a type approval or a CE marking according to the Medical Devices Act (MPG). A permit is also required for X-ray equipment used in technical radiography for coarse structure analysis in materials testing, for X-ray therapy, teleradiology, for early detection of diseases, for operation outside an X-ray room, in an X-ray room for another X-ray equipment (demonstration operation), or for operation in a mobile X-ray room. X-ray equipment that does not fall under this category is subject to notification.

Interference sources that fall under Annex 3, Part D of the Radiation Protection Ordinance (i.e. interference sources for which an accelerator voltage of 30 kV is not exceeded or those with type approval) do not require a permit, otherwise they must be approved. 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).

Detailed information can be obtained from the responsible trade supervisory office.

Prerequisites

  • Application or notification must be available;
  • Reliability of the applicant must be given;
  • Appointment of radiation protection officers;
  • Sufficient persons with the required expertise in radiation protection or with the required knowledge in radiation protection must be available;
  • 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;
  • 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 Inspection Office of the administrative district in which you have your business address (residence, if applicable). For the fastest possible processing of your application, it is recommended to use the online procedure mentioned below.

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 permit has been issued.

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: 27.07.2022

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
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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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.