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Installations for the production of ionizing radiation; application for a permit for operation or modification

The operation of a facility for the generation of ionizing radiation as well as the significant modification of the facility or its operation requires a permit and must be applied for with the competent authority.

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Procedure details

The operation of facilities for the generation of ionizing radiation in connection with therapeutic use on humans (new approval) as well as the significant modification of a facility or its operation (modification approval) requires a permit.

The Bavarian State Office for the Environment (LfU) as the competent authority issues the operating permit upon application. The documents and evidence required for the application for approval are regulated in the Radiation Protection Act (StrlSchG) and must be provided in the course of the procedure.

Applications for approval of a facility for the generation of ionizing radiation can be submitted to the LfU by companies, institutions and persons who wish to operate a facility in Bavaria.

General requirements for the granting of a license are regulated in the Radiation Protection Act (StrlSchG). A license is granted if

  • Applicants and radiation protection officers are reliable and competent,
  • Sufficiently qualified and trained personnel are available,
  • The necessary equipment is available and protective measures have been taken in accordance with the state of the art in science and technology,
  • The activity is justified and there are no other regulations to the contrary,
  • There is a legal provision for compensation,
  • Protection against interference and the effects of third parties is guaranteed

The LfU can limit the permit if the requirements can only be checked during trial operation. During trial operation, use on humans is excluded.

  • Documents required to apply for a permit for the operation or modification of ionizing radiation facilities;

    The following documents must be submitted:

    • Location of the plant
    • Information on the intended type of application
    • List of radiation protection officers
    • List of persons authorized for the application and technical implementation
    • Proof of acquisition of the required specialist knowledge in radiation protection
    • If applicable, proof of updating the required specialist knowledge in radiation protection
    • Proof of reliability (by means of a form or by submitting a police clearance certificate)
    • License to practice medicine
    • Proof of insurance to fulfill a legal obligation to pay damages (cover provision)
    • Technical equipment and operating data
    • Information on structural radiation protection
    • Information on safety systems
    • Information on the overall system
    • Information on quality assurance and physical radiation protection control
    • Radiation protection instructions
    • Proof of registration with the medical or dental authority (for use on humans)
    • Extract from the commercial register or partnership register
    • Radiation protection instructions

The necessary documents must be submitted to the LfU together with the application for an operating license.

The application can be submitted electronically via the application for the operation of an ionizing radiation facility (see "Online procedure").

The LfU checks the documents for completeness and compliance with the licensing requirements and, if necessary, requests the submission of missing evidence.

If necessary, the LfU may involve experts in the assessment process.

After a positive review of the application and all documents, the LfU issues the permit to operate the ionizing radiation facility.

The decision will be sent by post by the LfU.

165.00 to 6500.00 EUR

The application must be submitted in good time before the start of medical operations.

Beam generation and delivery may only take place once a permit has been issued. This also applies to the first beam emission during planned inspections and maintenance of the accelerator (e.g. the acceptance test of the structural radiation protection by the expert), unless this is carried out within the framework of a locally valid approval of the manufacturer under his responsibility under radiation protection law.

6 weeks to 6 months

The examination of the structural requirements for radiation protection is also examined by the LfU as part of the approval procedure. The LfU recommends contacting the authorities at an early stage and involving them in the planning process so that any structural requirements can be included in the construction planning.

An appeal against the decision may be lodged with the competent administrative court within one month of notification.

Status: 06.02.2026
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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