[논문]ISO14971:2019 세부분석과 Post Market Surveillance의 적용 방안 - IVDR 요구사항 중심으로

강일규

doi:10.9718/jber.2022.43.4.199

ISO14971:2019 세부분석과 Post Market Surveillance의 적용 방안 - IVDR 요구사항 중심으로
ISO14971:2019 detailed analysis and Post Market Surveillance Application Method - Focusing on IVDR requirements 원문보기

Journal of biomedical engineering research : the official journal of the Korean Society of Medical & Biological Engineering, v.43 no.4, 2022년, pp.199 - 213

강일규 (성균관대학교 삼성융합의과학원 의료기기산업학과)

Abstract ▼ AI-Helper

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 manufacturer 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.

주제어

표/그림 (15)

표 표 1. ISO14971:2007과 ISO14971:2019 조항 비교 Table 1. Comparison of clauses ISO14971:2007 vs ISO14971:2019
표 표 1. (continued) ISO14971:2007과 ISO14971:2019 조항 비교 Table 1. (continued) Comparison of clauses ISO14971:2007 vs ISO14971:2019
그림 그림 1. 위험관리 프로세스 도해 Fig. 1. Diagram of risk management process
표 표 2. 개발 단계에 따른 위험 관리 활동 요약 Table 2. Summary of risk management activities by development stage
그림 그림 2. 위험분석 프로세스 Fig. 2. Risk analysis process
표 표 3. 위험의 심각도 Table 3. Risk severity
그림 그림 3. 위험 평가 프로세스 Fig. 3. Risk evaluation process
표 표 4. 발생 가능성 Table 4. Probability of occurrence
표 표 5. 위험기반(Risk matrix) 수용도 기준 Table 5. Risk matrix acceptability criteria
그림 그림 4. 위험 통제 프로세스 Fig. 4. Risk control process
그림 그림 5. 전체 잔여위험 평가 프로세스 Fig. 5. Evaluation of overall residual risk process
그림 그림 6. 위험관리 보고서 프로세스 Fig. 6. Risk Management report process
그림 그림 7. 생산 및 생산 이후의 활동 프로세스 Fig. 7. Production and post production activity process
표 표 6. 생산 후 정보 예시 Table 6. Post Production information example
표 표 7. 제품 등급별 Post Market Surveillance(PMS) 업무 요약표 Table 7. Post Market Surveillance(PMS) summary table by product class

참고문헌 (18)

ISO 13485:2016: Medical devices, Quality management systems - Requirements for regulatory purposes. 2016, pp. 6.
ISO 14971:2007: Medical devices, Application of risk management to medical devices. 2007, pp. 1-5.
ISO 14971:2019: Medical devices, Application of risk management to medical devices. 2019, pp. 1-7.
ISO/TR 24971:2020: Medical devices, Guidance on the application of ISO 14971. 2020, pp. 63-85.
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. 1998, pp. 25.
EU IVDR REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. 2017;65.
MEDDEV 2.12/1 Rev. 8, GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM. 2013, pp. 13-26.
MEDDEV 2.12/2 Rev. 2, GUIDELINES ON MEDICAL DEVICES, POST MARKET CLINICAL FOLLOW-UP STUDIES, A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES. 2012, pp. 8-14.
NB-MED/2.12/Rec1 - Post-Marketing Surveillance(PMS) post market/production MINISTRY DECREE. 2005;1-9.
MDCG 2021-1, Rev.1, Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. 2021, pp. 23.
MDCG 2020-7, Rev.0, Post-Market Clinical Follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies. 2020, pp. 5-12.
MDCG 2020-8, Rev.0, Post-Market Clinical Follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies. 2020, pp. 4-9.
MDCG 2019-9, Rev.0, Summary of safety and clinical performance A guide for manufacturers and notified bodies. 2019, pp. 21-24.
MDITAC. Post-sales clinical follow-up care guidelines. 2012, pp. 4-6.
MFDS. 「In vitro diagnostic medical device manufacturing and quality control standards」. 2020, pp. 31.
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NIDS. Standard Trend Expert Newsletter, ISO 14971:2019 Major Revisions and Implications. 2020, pp. 4-11.
Min Woo Kang. Risk management application plan according to ISO14971:2019-Analysis through risk management of VR medical devices. Medical Device Engineering and Management. The Graduate School, Yonsei University. 2020, pp. 10-13.

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