문화기술의 융합 (The Journal of the Convergence on Culture Technology)

  • 제8권5호
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  • Pages.29-37
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  • 2022
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  • 2384-0358(pISSN)
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  • 2384-0366(eISSN)
국제문화기술진흥원 (The International Promotion Agency of Culture Technology)
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유럽의 새로운 의료기기 규제제도 MDR

New Medical Device Regulations (MDR) in Europe

  • 투고 : 2022.07.04
  • 심사 : 2022.08.31
  • 발행 : 2022.09.30
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초록

2017년 새롭게 제정된 유럽의 새 의료기기 규제법인 MDR은 기존의 CE 적합성 인증을 받은 의료기기 제품들이 새로운 CE의 MDR규정에 맞춰 2024년 5월까지 인증을 받도록 요구하고 있다. 새로운 MDR 적합성 요구사항은 기존보다 강화된 의료기기 임상평가 및 임상 조사를 요구하며 또한 문서화된 시판후 임상 추적 자료의 제출을 요구한다. 한국의 의료기기 업체들도 새로운 MDR 요구사항을 맞춰 적합인정을 받아야 하나, 새로우 규정을 정확히 이해하지 못하여 산업계의 혼란은 계속 되고 있다. 본 연구에서는 한국과 미국의 의료기기 관련 규정을 알아보고, 또한유럽의 의료기기법인 MDR을 기존의 유럽 의료기기 지침인 MDD와 비교함으로써 유럽 의료기기법의 요구 사항들을 이해하는데 도움이 되고자 한다.

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

키워드

과제정보

이 논문은 2022년도 을지대학교 대학혁신지원사업 지원으로 연구되었음.

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