responsibility finder
Schleswig-Holstein

Display operation or significant change in operation of dental, medical and veterinary X-ray equipment

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

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.


Process flow
  • 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.
Competent authority

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

Requirements

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.
Which documents are required?
  • 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
What are the fees?

Fee: 100,00 - 2500,00 EUR
Payment in advance: no

What deadlines do I have to pay attention to?

Application deadline: 4 Weeks
Before commissioning the X-ray equipment

Processing duration

Processing time: 4 Weeks
Depending on the scope of the application and completeness of the documents, usually 2-4 weeks

Legal basis
Applications / forms
What else should I know?
Author

The text was automatically translated based on the German content.

Teaser

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.

Process flow

  • 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.

Competent authority

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

Requirements

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.

Which documents are required?

  • 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

What are the fees?

Fee: 100,00 - 2500,00 EUR
Payment in advance: no

What deadlines do I have to pay attention to?

Application deadline: 4 Weeks
Before commissioning the X-ray equipment

Processing duration

Processing time: 4 Weeks
Depending on the scope of the application and completeness of the documents, usually 2-4 weeks

Legal basis

Applications / forms

What else should I know?

Author

The text was automatically translated based on the German content.

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