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.
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 EURPayment in advance: no
What deadlines do I have to pay attention to?
Application deadline: 4 WeeksBefore commissioning the X-ray equipment
Processing duration
Processing time: 4 WeeksDepending 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.