이레경영컨설팅

MDR CE

CE Marking 이란 ?

MDR 개요

TCF(Technical Document)에 포함될 내용

  1. 1) MDR Annex1의 GSPR(General Safety and Performance Requirements) Check List 작성
  2. 2) Biological Safety Assessment Report (ISO10993-1:2018)
  3. 3) Risk Management Plan (ISO14971:2019)
  4. 4) Risk Management Report
  5. 5) Usability Validation Plan (IEC62366-1:2015)
  6. 6) Usability Validation Report
  7. 7) Clinical Evaluation Plan (MEDDEV 2.7/1 :2016
  8. 8) Clinical Literature Search Protocol
  9. 9) Clinical Literature Search Report
  10. 10) Adverse Event Search Report
  11. 11) Clinical Evaluation Report
  12. 12) 공정 (멸균, 세척, 포장, Clean Room) Validation Report 준비
  13. 13) Software Validation Plan
  14. 14) Software Validation Report
  15. 15) 제품도면 및 개략도
  16. 16) 제조공정도
  17. 17) User Manual (Instructions for use)
  18. 18) 사용원자재 List(중요부품) 등
  19. 19) Product Label
  20. 20) SSCP(Summary of safety and clinical perpormance)매년 up load : Implantable 및 Class III Article 32
  21. 21) PSUR(Periodic Safety Update Report) 정기적으로 up date : IIa, IIb, III 제품 Article 86
  22. 22) DOC (Declaration of Conformity)

주요 개정 내용