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If you want to operate an X-ray device that has a CE mark or type approval, you must report this.

You may only operate an X-ray facility once you have received confirmation of the required notification from the responsible authority.
If you wish to make significant changes to the operation of an existing X-ray facility, you must also notify us.

Submit the following documents with the written notification, which must be signed by the person responsible for radiation protection:

A) For technical X-ray equipment:

• Copy of the certificate of an officially appointed expert including the test report
• Copy of the approval certificate for the type of X-ray tube
• Proof that the number of radiation protection officers necessary for the safe operation of the X-ray facility has been appointed and that they have been granted the powers required to carry out their duties
• Proof that each radiation protection officer has the necessary expertise or, if a radiation protection officer is not necessary, the radiation protection officer has the necessary expertise in radiation protection
• Proof that the persons otherwise involved in the operation of the X-ray facility have the necessary knowledge and skills with regard to the possible radiation hazard and the protective measures to be applied

B) For basic, high or full protection device or school X-ray equipment:

• Copy of the approval certificate for the type of X-ray device
• Proof of the quality control carried out with the result that the X-ray equipment complies with the essential characteristics of the type approval for radiation protection
• Proof that each radiation protection officer has the necessary expertise or, if a radiation protection officer is not necessary, the radiation protection officer has the necessary expertise in radiation protection,
• Proof that the persons otherwise involved in the operation of the X-ray equipment have the necessary knowledge and skills with regard to the possible radiation hazard and the protective measures to be applied.

You either want to operate an X-ray facility with a CE marking or type approval or make significant changes to the operation of an existing X-ray facility.

To do so, you must meet the following requirements or take steps within a reasonable time to be able to meet them in the future:

• There must be no concerns regarding the reliability of the person responsible for radiation protection or the person in charge of radiation protection.
• There must be no doubt that the necessary personnel are available to carry out the activity safely.
• The activity must be justified or there must be no significant doubt as to its justification.
• You must not have violated the provisions of the Radiation Protection Act or the regulations based on it.
• The X-ray equipment must not pose a significant risk to your employees, other persons or the general public.
• No other public law provisions may conflict with the intended activity.
• The same applies if you want to make significant changes to the operation of an X-ray facility.

The confirmation of notification is subject to a fee. The fees are calculated according to the time spent in accordance with § 2 of the fee schedule.

• You fill out the relevant notification form completely and send it, together with the required documents, to the responsible authority.
• The responsible authority will examine your notification and your documents.
• If necessary, the responsible authority will request further documents or information from you.
• If the requirements for the advertisement are met, you will receive a confirmation of the advertisement.
• The fee notice will usually be sent to you separately.
• Once you have received confirmation of the notification, you are permitted to operate the X-ray device.
• If you have not received any notification to the contrary from the responsible authority within 4 weeks of your notification, you can also put the X-ray device into operation.

Processing usually takes 4 weeks.

You must submit the notification to the responsible authority at least 4 weeks before the initial commissioning.
The X-ray device can be put into operation once you have received confirmation of notification from the responsible authority.
If you have not received any notification to the contrary from the responsible authority within 4 weeks of your notification, you can also put the X-ray device into operation.

The operation of an X-ray device without the required display is prohibited.

Objection within one month of receipt of the decision

• Report operation of an X-ray device or significant change in the operation of an existing X-ray device
• Notification of the operation of an X-ray facility or of a significant change in its operation
• Notification of the operation of X-ray equipment in accordance with Section 19 of the Radiation Protection Act, including all required documents
• Notification of a significant change to X-ray equipment according to Section 19 StrlSchG,
• Only the person responsible for radiation protection according to § 69 StrlSchG can submit the application
• Confirmation of advertisements is subject to a fee
• Notification form at https://www.hamburg.de/formulare/nutzen.

Justice and Consumer Protection Authority