Betrieb oder wesentliche Änderung des Betriebs einer zahnmedizinischen, medizinischen und tiermedizinischen Röntgeneinrichtung anzeigen

If you intend to operate or significantly modify a dental, medical or veterinary X-ray facility and this is not subject to approval, you are obliged to notify the competent authority.

With the written notification of a dental, medical or veterinary X-ray facility, you declare that you intend to operate or significantly modify such a facility.

• Proof of expertise in radiation protection in accordance with the Radiation Protection Ordinance with proof of updating
• Certificate and test report from the expert(s) on the radiation protection test
• Type approval certificate with unit test confirmation (if applicable) (type approval = for device in general; unit test confirmation = for the specific device)
• CE certificate of conformity (if applicable)
• Personnel deployment, i.e. proof of knowledge of radiation protection and updates of this knowledge for personnel working on the X-ray equipment

You want to either

• operate an X-ray unit,
  • whose X-ray source is type-approved in accordance with § 45 paragraph 1 number 2,
  • the manufacture and first placing on the market of which falls within the scope of the Medical Devices Act, or
  • the manufacture and placing on the market of which falls within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1; L 117, 3.5.2019, p. 9; L 334, 27.12.2019, p. 165)
  • which has been placed on the market for the first time in accordance with the provisions of the Medical Devices Act and is not used in connection with medical exposures; or

• you wish to operate a basic, high or full protection device or a school X-ray device; or
• substantially change the operation of such a notified X-ray device and you have a license in accordance with §15 StrlSchG.

• You submit a written notification to the competent authority. In it, you declare whether you are operating or significantly modifying dental, medical or veterinary X-ray equipment.
• The notification must be submitted before the X-ray equipment is put into operation or significantly modified.
• The competent authority will check the documents and send you a notification confirmation with a fee notice.

• Operation of an X-ray facility or significant change to the operation Acceptance for dental, medical or veterinary X-ray facilities
• Notification in writing or online
• Responsible: Radiation Protection Department in the Ministry for Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein

The Radiation Protection Department in the Ministry for Energy Transition, Climate Protection, Environment and Nature of the State of Schleswig-Holstein