Service Finder
NiSV - Notification of the operation of non-ionizing radiation sources for cosmetic or other non-medical use
Service Description
In accordance with § 3 para. 3 sentences 1, 2 and 4 of the Ordinance on Protection against Harmful Effects of Non-Ionizing Radiation in Human Applications (NiSV), the competent authority must accept notification of the commissioning or operation of existing installations within the meaning of § 2 para. 1 NiSV before 31 December 2020.
Fulfillment of the legal obligation to notify.
Process flow
According to § 3 para. 3 sentences 1, 2 and 4 NiSV, the operator of the plant must provide information on the identity of the operator or the company, the address of the operating site and information on the identification of the plant(s) or combination device(s) as well as the type of application(s).
The person(s) using each system(s) must be named (§ 3 Para. 1 No. 2 NiSV).
As of 31.12.2022, the obligation to provide evidence of the specialist knowledge of the person(s) using the device(s) applies. This evidence must then be enclosed with the notification.
After receipt of the notification(separately for each plant), the authority must immediately issue a notification if the notification is incomplete.
Who should I contact?
Contact the Thuringian State Office for Consumer Protection (TLV), Department of Technical Consumer Protection, Market Surveillance in Suhl.
Requirements
For applications in accordance with § 5 Para. 2, § 6 Para. 2, § 8 and § 9 Para. 2 NiSV, it applies from 31.12.2020 that only licensed physicians with appropriate further medical training may perform these.
Magnetic resonance tomographs - MRI (§ 11 NiSV) may only be used from 31.12.2020 under the responsibility of a doctor with a specialist qualification in the proper operation of MRI.
Which documents are required?
In addition to the notification, proof of the obligation of a licensed physician with appropriate further medical training is required for applications in accordance with § 5 Para. 2, § 6 Para. 2, § 8 and § 9 Para. 2 NiSV.
In the case of the use of magnetic resonance tomographs - MRI (§ 11 NiSV), proof must be submitted that the person using the device is a physician with a specialist qualification in the proper operation of MRI.
What are the fees?
none
What deadlines do I have to pay attention to?
In the case of the acquisition of systems in accordance with § 2 Para. 1 NiSV from 31.12.2020, the notification must be made no later than two weeks before commissioning.
Plants that have already been operated before 31.12.2020 must be notified by the end of 31 March 2021.
Legal basis
Appeal
The application may be submitted informally. It is recommended to use the application according to
§ Section 3 (3) of the NiSV. Electronic submission of the documents is possible.
What else should I know?
Observance of the requirements of § 3 (1) and (2) NiSV on general requirements for the operation of the plant(s) and the documentation obligations.
Author
The text was automatically translated based on the German content per DeepL.
Technically approved by
Thuringian Ministry of Labor, Social Affairs, Health, Women and Family (TMASGFF)
Professionally released on
16.11.2021
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
No competent authority found
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