X-ray facilities for teleradiology and screening; application for authorization to operate.

If you wish to operate an X-ray facility for teleradiology or screening, you must apply for a permit from the competent authority.

Description

Prerequisites

The permit application and the required documents and evidence must be submitted to the competent authority.

    Procedure

    You make the application for approval and submit it together with the required documents/evidence.

    The Government of Lower Franconia Trade Inspectorate (X-ray Competence Center) checks the application and the documents for completeness and correctness. If the submitted documents are complete and plausible, the requested permit will be issued by the responsible authority.

    To ensure that your application is processed as quickly as possible, we recommend using the online procedure.

    Deadlines

    none

    Required documents

    • Required Documents:

      Application for authorization for teleradiology

      • List of authorized persons for technical implementation (MTRA) with proof of authorization according to MTA law and, if applicable, proof of updating
      • List of teleradiologists with certificates of radiation protection expertise and proof of updating, if applicable
      • List of physicians at the examination site with proof of knowledge in radiation protection or corresponding expertise and, if necessary, proof of updating.
        Furthermore, the instruction of these persons for the performance of examinations within the scope of teleradiology must be confirmed by a teleradiologist.
      • Proof of a medical physics expert who can be consulted during operation of the X-ray facility.
      • Cooperation agreement between the operator of the X-ray facility and the cooperation partner for teleradiology.
      • Radiation protection instructions and work instructions for carrying out teleradiology
      • Copy of the expert inspection report of the X-ray facility used for teleradiology
      • List and locations of the image reproduction devices of the teleradiologists
      • Proof of testing of the image reproduction devices of the teleradiologists according to DIN 6868-157
      • Evidence for testing the data transmission links to the locations of the image reproduction devices of the teleradiologists according to DIN 6868-159
      • Designation of the responsible teleradiologist(s)
      • Designation of the radiation protection officer(s) (SSB) for the operation of the X-ray equipment intended for teleradiology.
      • Justification for the extended teleradiology operation (see also separate form), if this is requested.

      Application for approval for screening

      • List of x-ray facilities, x-ray-assisted biopsy equipment, stand-alone reporting facilities, and physicians working in the screening unit.
      • Printout of the approval of the Kassenärztliche Vereinigung Bayerns (Association of Statutory Health Insurance Physicians of Bavaria) regarding the assumption of the care mandate.
      • Proof of certification or current recertification of the screening unit by the Mammography Cooperation Association.
      • Prints of the notification confirmations (or approvals) for the curative operation of all X-ray equipment/X-ray-assisted biopsy equipment used in the screening unit.
      • If applicable, orders for the required radiation safety officers for screening operations with respect to each screening facility.
      • Prints of the cooperation agreements (memoranda of understanding) between the radiation protection officers of the mammography X-ray facilities used in the screening unit and the program manager (PVA) concerning the assignment of duties and the performance of all responsibilities and powers, including the necessary regulations concerning the authority to issue instructions within the scope of the screening operation by the PVA(s).
      • Evidence of compliance with the requirements of No. 6.5.2 PAS (Publicly Available Specification) 1054 (Requirements and test procedures for digital mammography facilities).

    Online procedures

    Fees

    • The costs for the approval depend on the respective administrative effort incurred. They amount to between 250 and 500 EUR per application.

    Links to more information

    Status:12.06.2023

    Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

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    • 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
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