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European Medical Device Regulations
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| Author:
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PRINEETHA M, VYSHNAVI TALLAPANENI, MAHENDRAN BASKARAN, VEERA VENKATA SATYANARAYANA REDDY KARRI
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| Abstract:
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Medical devices are equipment or products usually designed for medical use. They are controlled by national competent officials, but the European Medicines Agency (EMA) also participates in the evaluation of certain classifications of medical devices under European Union (EU) laws.EU has adopted new medical device regulation 2017/745, it has a transition period of 3 years and will be applied fully from 26 May 2020. During the transition period the manufacturer may place their device on the market in accordance with the latest regulations if they comply or in accordance with EU directives which are currently in force. Medical device regulations will be focusing on clinical evaluation and clinical investigation which ensure the device are safe and effective.
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| Keyword:
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Medical Devices, European Union, Regulations
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.02.0016
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| Download:
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Request For Article
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