체외진단의료기기의 국내와 유럽에서의 허가(인증) 및 임상적 성능시험 경험
Experience of Approval of In Vitro Diagnostic Medical Devices in Korea and Europe and Clinical Performance Study
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
배경: 국내에서는 2020년 5월 1일 체외진단의료기기법이 시행되었고, 유럽에서는 2022년 5월 26일 새로운 체외진단의료기기규정(in vitro diagnostic medical device regulation, IVDR)이 기존의 체외진단의료기기지침(in vitro diagnosis medical device directive, IVDD) 을 대체하였다. 두 가지 새로운 규정에 맞춰서 체외진단의료기기허가(인증)를 받는 과정을 공유하고자 한다. 방법: NextGene MTB/NTM Detection Kit와 NextGene STI 12 Detection Kit 3&4 두 가지의 키트의 임상적 성능시험을 포함한 허가(인증) 과정을 진행하였다. 결과: 임상적 성능시험에서 NextGene MTB/NTM Detection Kit는임상적 민감도와 특이도, 양성 일치도와 음성 일치도 모두 100%를보였고, NextGene STI 12 Detection Kit 3&4 또한 과학적 유효성기준에 합당하였다. NextGene MTB/NTM Detection Kit는 국내식품의약품안전처 3등급 허가와 IVDR class C 인증을 획득하였다. NextGene STI 12 Detection Kit 3&4는 IVDD others 자가선언을통해 등록하였다. 결론: NextGene MTB/NTM Detection Kit와 NextGene STI 12 Detection Kit 3&4 모두 임상적으로 사용하는데 적합한 성능을 보였다. 이러한 성능을 바탕으로 국내 및 유럽 허가(인증)를 획득하였다. 본 연구는 직접 진행한 전체 국내 및 유럽 허가과정을 포함하고 있으며, 추후 허가(인증)를 진행하는 관련자들에게 도움이 될것이다.
Abstract
Background: In Korea, the In Vitro Diagnostic Medical Devices (IVD) Acts was first enforced in May 2020. The European In Vitro Diagnosis Medical Device Directive (IVDD) was replaced by the In Vitro Diagnostic Medical Device Regulation (IVDR) in May 2022. In this paper, the domestic (Korea) and European approval processes were reviewed. Methods: We proceeded with the approval process, including clinical performance study, for two real time PCR assays, namely NextGene MTB/ NTM Detection Kit (EONE BIOTECH, Korea) and NextGene STI 12 Detection Kit 3&4 (EONE BIOTECH). Results: In the clinical performance study, the clinical sensitivity, clinical specificity, positive percentage agreement, and negative percentage agreement of the NextGene MTB/NTM Detection Kit were 100%. The NextGene STI 12 Detection Kit 3&4 also met the scientific validity criteria. After completing the clinical performance study, the NextGene MTB/NTM Detection Kit obtained class III approval from the Ministry of Food and Drug Safety (MFDS) and was certified by a notified body in accordance with the IVDR as class C. The NextGene STI 12 Detection Kit 3&4 was self declared as others in accordance with the IVDD. Conclusions: The NextGene MTB/NTM Detection Kit and NextGene STI 12 Detection Kit 3&4 showed clinically comparable performances. We also proceeded with the approval processes based on clinical performance study data. This study included both domestic and European approval processes. We believe that this study will serve as a helpful guide for those seeking to proceed with future approvals.
참고문헌 (27)
- "Act on in vitro diagnostic medical devices. Act no. 16433" (2023)[URL]
- "Regulation on Notification, Certification and Approval of In Vitro Diagnostic Medical Devices. Notification no. 2022 -9" (2023)[URL]
- "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)" (2023)[URL]
- "MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to 'legacy devices' and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC" (2022)[URL]
- "A study on the investigation of new medical device classification and management system in major countries. KHIDI-CHIP-R-2021-5" (2022)[URL]
- "Food & Drug Statistical Yearbook 2022. GPRN 11-1471000-000165-10" (2022)[URL]
- Kim S, "Current status and perspectives for in vitro medical devices for infectious disease diagnosis-Survey of product development and clinical tirals", Lab Med Online, 13, pp.65~71 (2023)
- Cho WH, "Comparison of AdvanSure TB", NTM PCR and COBAS TaqMan MTB PCR for detection of Mycobacterium tuberculosis complex in routine clinical practice, 2015, pp.35, 356~361
- Huh HJ, "Comparison between DiaPlexQ™ STI6 and GeneFinder™ STD I", STD II multiplex Real-time PCR Kits in the detection of six sexually transmitted disease pathogens, 2019, pp.33, e22703~
- Bougnoux ME, "Usefulness of multilocus sequence typing for characterization of clinical isolates of Candida albicans", J Clin Microbiol, 40, pp.1290~1297 (2002)
- "Guildeline on the the clinical performance study of in vitro diagnostic medical devices" (2020)[URL]
- "Guideline on the clinical performance study of in vitro diagnostic medical devices for high risk pathogens" (2022)[URL]
- "Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices" (2012)[URL]
- Hallersten AM, "Principles of ideal diagnostic regulation and the IVDR", Clin Chem Lab Med, 61, pp.599~607 (2022)
- Kahles A, "Structure and content of the EU-IVDR : current status and implications for pathology", Pathologie(Heidelb), 44(S2), pp.73~85 (2023)
- Nayak S, "EU IVDR regulatory changes : an overview of requirements in(EU)2017", 746, 2020, pp.7, 237~243
- "List of notified bodies under Regulation (EU) 2017/746 on in vitro diagnostic medical devices"[URL]
- "Proposal for a Regulation (EU) 2017/746 of the European Parliament and of the Council amending Reulation (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisons for certain devices and in vitro diagnostic medical devices (Text with EEA relevance)"[URL]
- Lubbers BR, "The new EU regulation on in vitro diagnostic medical devices : implications and preparatory actions for diagnostic laboratories", HemaSphere, 5, pp.e658~ (2021)
- Majety RP, "New era in medical device regulations in the European Union", Pharm Regul Aff, 10, pp.2~ (2021)
- Lee EH, "A proposal to improve clinical performance tests according to domestic in vitro diagnostic medical device license management", Master, pp.2021
- Lee H, "Impact of public health interventions on seasonal influenza activity during the COVID-19 outbreak in Korea", Clin Infect Dis, 73, pp.e132~e140 (2021)
- "Management Tailored to In Vitro Diagnostic Devices, such as Diagnostic Agents for COVID 19" (2020)[URL]
- Yun SG, "Initial response of the Korean Society for Laboratory Medicine to the COVID-19 pandemic", Lab Med Online, 11, pp.217~222 (2021)
- Hong KH, "Guidelines for laboratory diagnosis of coronavirus disease 2019(COVID-19)in Korea", Ann Lab Med, 40, pp.351~360 (2020)
- Hong KH, "Update of guidelines for laboratory diagnosis of COVID-19 in Korea", Ann Lab Med, 42, pp.391~397 (2022)
- Roh KH, "Guidelines for mobile laboratories for molecular diagnostic testing of COVID-19", Ann Lab Med, 42, pp.507~514 (2022)