Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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ISO14971:2019 Detailed Analysis and Periodic Safety Update Report Establishment Method for the Single Use Medical Device - Focusing on Medical Device Regulation 2017/745 requirements

일회용 의료기기에 적용을 위한 ISO 14971:2019 분석과 Periodic Safety Update Report 작성 방법 - Medical Device Regulation 2017/745 요구사항 중심으로

  • Sang Min, Park (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University) ;
  • Gyu Ha, Ryu (Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Research Institute for Future Medicine, Samsung Medical Center)
  • 박상민 (성균관대학교 삼성융합의과학원 의료기기산업학과) ;
  • 류규하 (성균관대학교 삼성융합의과학원 의료기기산업학과, 삼성서울병원 미래의학연구원)
  • Received : 2022.10.15
  • Accepted : 2023.01.10
  • Published : 2023.02.28
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Abstract

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

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References

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