MDR 구성

Medical Device Regulation

10 Chapter + 17 Annexes

 

CHAPTER

1. Scope and Definition
2. Making Available on the Market, CE marking, Free movement(*자유 유통)
3. Identification and Tracebility of Devices(UDI, EUDAMED 관련), Registration of Devices and Economic Operators
4. Notified Bodies(NB)
5. Clssification and Conformity Assessment
6. Clinical evalutation and Clinical Investigations
7. Post-Market Surveillance(PMS), Vigilance and Market Suveillance
8. Cooperation between member states and commission(MDCG 협력 규정)
9. Confidentiality, Data Protection, Funding and Penalties (비밀유지, 데이터 보호, 재정, 제재)
10. Final Provisions (최종 조항-MDD, AIMDD 폐지조항)

 

ANNEX

Annex I	General Safety and Performance Requirements (GSPR)	필수 안전·성능 요구사항 (기존 Essential Require-ments 대체)
Annex II	Technical Documentation	기술문서(기본 TD) 구성요소 명시
Annex III	Technical Documentation on Post-Market Surveillance	시판 후 감시 문서 요구사항
Annex IV	EU Declaration of Conformity	EU 적합성 선언서 양식
Annex V	CE Marking of Conformity	CE 마킹 표시 규칙
Annex VI	Information to be Submitted to EUDAMED	EUDAMED 등록 데이터 형식 및 절차
Annex VII	Requirements for Notified Bodies	인증기관 지정 및 운영요건
Annex VIII	Classification Rules	의료기기 등급 분류 규칙 (총 22개 Rule)
Annex IX	Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation	품질시스템(QMS) 및 기술문서 평가 기반 인증 절차
Annex X	Conformity Assessment Based on Type Examination	형식시험(Type Examination) 절차
Annex XI	Conformity Assessment Based on Product Conformity Verification	제품 적합성 검증 절차
Annex XII	Certificates Issued by a Notified Body	인증서 유형 및 형식
Annex XIII	Procedure for Custom-Made Devices	맞춤형 의료기기 절차
Annex XIV	Clinical Evaluation and Post-Market Clinical Follow-up	임상평가 및 시판 후 임상추적 절차
Annex XV	Clinical Investigations	임상시험 수행 기준
Annex XVI	Devices Without an Intended Medical Purpose	비의료 목적 기기에 대한 추가 요구사항
Annex XVII	Correlation Table (MDD/AIMDD 대비표)	MDD/AIMDD 대비표 (참고용)

 

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