eISSN: 2084-9885
ISSN: 1896-6764
Neuropsychiatria i Neuropsychologia/Neuropsychiatry and Neuropsychology
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SCImago Journal & Country Rank
2/2016
vol. 11
 
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abstract:
Review paper

Legal aspects of use and maintenance of a neurotherapeutic device

Maciej Łukasz Siedlecki
,
Rafał Łukasz Szewczyk
,
Marta Agnieszka Ratomska

Neuropsychiatria i Neuropsychologia 2016; 11, 2: 80–83
Online publish date: 2016/09/19
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Nowadays in Poland more and more neurotherapeutic devices are used, such as biofeedback, tDCS and TMS. Private and public therapeutic centers often decide to purchase this kind of device. Apart from legal aspects of using and conducting neurotherapy (Szewczyk et al. 2016), the consequences of purchase and service of a neurotherapeutic device should be considered. From the legal point of view, neurotherapeutic apparatus can be divided into: 1) medical devices, which are described in the act of 20 May 2010 on medical devices, and 2) devices without the medical status but having the “Conformité Européenne” (CE) mark. Whether the apparatus is a medical one or not has a number of consequences for people managing the therapeutic centers and also for business entities that implement this kind of device. The law imposes the obligation of conducting the appropriate service and documentation of every medical device. However, devices of similar properties without the medical status do not have to fulfill these requirements. It should also be noted that the service of a medical device can be provided by any entity that has the appropriate technical facilities, knowledge and experience, and not exclusively by those that are suggested by the importer or the producer of the device. The aim of this article is to discuss the obligations resulting from the law about the medical device and to present the consequences of this law, which users of the neurotherapeutic device should be aware of.
keywords:

neurotherapy, biofeedback, tDCS, TMS

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