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KMID : 1137820220430040199
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의공학회지
2022 Volume.43 No. 4 p.199 ~ p.213
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ISO14971:2019 detailed analysis and Post Market Surveillance Application Method - Focusing on IVDR requirements
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Kang Il-Kyu
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Abstract
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EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the man- ufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.
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KEYWORD
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ISO14971, Risk management, Post market surveillance (PMS), In vitro diagnostic medical device (IVD)
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