X-ray equipment and sources of interference; application for a licence for operation or notification of operation

As a rule, the operation of an X-ray device or an interference source is either subject to approval or requires notification. This depends on the type of device or its use. The Trade Inspectorate or the State Office for the Environment issues the permit or accepts the notification upon your application.

Description

The operation of X-ray equipment is subject to approval if it has neither a type approval nor 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 falling under Annex 3, Part D StrlSchV (i.e. interference sources for which an accelerator voltage of 30 kV is not exceeded or those with design approval) do not require a licence, otherwise they must be licensed. 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;
  • Nomination 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 in accordance with MPG);
  • The activity must be fundamentally justified;
  • Other regulations under public law must not be in conflict;
  • For the medical sector, there are further requirements such as presentation of the licence to practise medicine, display instrument for radiation exposure, involvement 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, 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 at the earliest four weeks after notification to the responsible trade supervisory office. Operation at an earlier time is only permissible if the office issues the operating permit within the scope of a notification confirmation.
In the approval procedure, the X-ray equipment or the source of interference 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 costs for an approval range from EUR 75.00 to EUR 500.00 per device.
    The notification procedure is free of charge.

Status: 29.12.2021

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
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.