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

박상민; 류규하

doi:10.9718/jber.2023.44.1.1

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

Journal of biomedical engineering research : the official journal of the Korean Society of Medical & Biological Engineering, v.44 no.1, 2023년, pp.1 - 10

박상민 (성균관대학교 삼성융합의과학원 의료기기산업학과) , 류규하 (성균관대학교 삼성융합의과학원 의료기기산업학과, 삼성서울병원 미래의학연구원)

Abstract ▼ AI-Helper

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.

주제어

표/그림 (15)

표 표 1. ISO 14971:2007과 ISO 14971:2019 조항 비교[10] Table 1. Comparison of clauses ISO 14971:2007 vs ISO14971:2019[10]
그림 그림 1. 위험관리 프로세스 도해[10] Fig. 1. A schematic representation of the risk management
표 표 2. 위험평가 5×5 matrix 적용 예시[11] Table 2. Example of risk evaluation adoption by 5×5 matrix[11]
표 표 3. 위험분석 예시[10] Table 3. Example of Risk Analysis[10]
표 표 4. 위험산정(risk estimation) 예시 Table 4. Example of risk estimation
표 표 5. 위험평가 예시4 Table 5. Example of risk evaluation
표 표 6. DPI를 적용한 위험 통제 예시 Table 6. Example of DPI adopted risk control
표 표 7. 잔여위험 평가 예시 Table 7. Example of Residual risk evaluation
표 표 8. 잔여위험 평가 및 이익-위험 분석 예시 Table 8. Example of Residual risk evaluation and Benefit-risk analysis
표 표 9. 전체 잔여위험 평가 예시 Table 9. Example of total residual risk assessment
그림 그림 2. PSUR 프로세스 순서 및 주요 활용 데이터 Fig. 2. PSUR Process Flow and main applicable data
표 표 10. 적극적인 정보수집과 수동적인 정보수집 예시 Table 10. Example of pro-active and passive information
표 표 11. PMS, PMCF 참고문서 목록 Table 11. Reference documents list for PMS, PMCF
표 표 12. 나라별 회수 정보 사이트 Table 12. A site of information for the recall of medical device by country
표 표 13. PMCF 발견사항기재 필수 항목 Table 13. A content of PMCF findings essential requirements

참고문헌 (14)

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MOLEG. Medical Device Act Enforcement Rules; on Dec？19 2022. Attached form 1 of Article 2 related.
MDCG 2021-24, Guidance on classification of medical devices;？2021;5.
ISO 14971:2019 Medical devices, Application of risk management to medical devices, 2019;1-46.
ISO/TR 24971:2020 Medical devices, Guidance on the application of ISO 14971. 2019;22-49.
https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm？Accessed on 10 Jan 2023.
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