Information - Röntgeneinrichtungen und Störstrahler; Beantragung einer Genehmigung für den Betrieb bzw. Anzeige des Betriebs - Dienstleistungsportal Bayern

Description

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.

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 a type approval) do not require a permit, otherwise they require a permit. 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

• 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 of 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, it is recommended - if available - to use the corresponding online procedures.

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.

• Prefillable Form, Bavaria-wide: Erklärung zum Betreiberwechsel/beitritt Betrieb von Röntgeneinrichtungen nach §§ 12 Abs. 2 und 19 Abs. 5 Strahlenschutzgesetz (StrlSchG)

  Please note

  This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

• Prefillable Form, Bavaria-wide: Anzeige von Tätigkeiten nach §§ 22 und 26 Strahlenschutzgesetz (StrlSchG)

  Please note

  This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

• Prefillable Form, Bavaria-wide: Meldung eines bedeutsamen Vorkommnisses nach § 108 Strahlenschutzverordnung (StrlSchV)

  Please note

  This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

Online procedures

• Anzeige/Genehmigungsantrag nach Strahlenschutzgesetz (StrlSchG)

  You can submit the notification or application for authorization under the Radiation Protection Act online.

• Mitteilung der Bestellung, Änderung oder Abbestellung von Strahlenschutzbeauftragten nach § 70 Strahlenschutzgesetz (StrlSchG)

  You can submit a notification of appointment, change or cancellation of radiation protection officers online in accordance with Section 70 of the Radiation Protection Act (StrlSchG).

• Fachkundebescheinigung Technik: Röntgen, radioaktive Stoffe oder Medizinphysik-Experte

  You can apply online for the certificate of technical expertise according to § 47 of the Radiation Protection Ordinance (StrlSchV).

Fees

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

Legal bases

• Gesetz zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzgesetz – StrlSchG)
• Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung (Strahlenschutzverordnung – StrlSchV)
• Tarif-Nr. 7.II.13 Anlage der Verordnung über den Erlass des Kostenverzeichnisses zum Kostengesetz (Kostenverzeichnis - KVz)
• Fristverlängerung für die Konstanzprüfungen von Röntgeneinrichtungen - Allgemeinverfügung der Bayerischen Gewerbeaufsichtsämter vom 13. Juni 2003

  Az.: 5.6/3443/150/03

• Gesetz über Medizinprodukte (Medizinproduktegesetz - MPG)
• Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten (MPBetreibV)

Links to more information

• Röntgenstrahlung - Zuständigkeiten und Aufgabenverteilung
• Bayerische Gewerbeaufsicht
• Merkblatt "Behördliche Verfahren zum Betrieb von Röntgeneinrichtungen im Freistaat Bayern"
• Merkblatt "Teilkörper-Dosimetrie / Dosismessungen an strahlenexponierten Körperteilen nach § 35 RöV"
• Merkblatt "Übersicht der Strahlenschutzmaßnahmen"
• Vollzug der Röntgenverordnung (RöV) - Gestattung einer Abweichung von den Vorgaben zur Abnahmeprüfung bei dentalen Röntgentubuseinrichtungen - Allgemeinverfügung der Bayerischen Gewerbeaufsichtsämter

Related issues

• Trade inspection; information on the examination of legally required notifications
• X-ray equipment and interfering radiators; transmission of test reports by experts
• X-ray facilities for teleradiology and screening; application for authorization to operate.