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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
The National Council Licensure Examination (NCLEX) is a nationwide examination for the licensing of nurses in the United States, Canada, and Australia since 1982, 2015, and 2020, respectively. [2] [3] There are two types: the NCLEX-RN and the NCLEX-PN. After graduating from a school of nursing, one takes the NCLEX exam to receive a nursing license.
Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union; Medical Device Regulation Act of 1976 in the United States
The CNO's definition for a nurse's scope of practice is: "The practice of nursing is the promotion of health and the assessment of, the provision of care for, and the treatment of health conditions by supportive, preventive, therapeutic, palliative, and rehabilitative means in order to attain or maintain optimal function".
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017. [11]
Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR .
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
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