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.

Technically approved by

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

Professionally released on

06.04.2022

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.

Technically approved by

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

Professionally released on

06.04.2022

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