3 Meddev Solutions Limited (RAPS e-Book version)
Contents
CONTENTS
CHAPTER 1 1
Welcome 1
CHAPTER 2 2
Background to the IVDR 2
CHAPTER 3 9
How to use this guidebook 9
CHAPTER 4 11
Compliance guide 11
CHAPTER 5 21
Device Classification 21
Classification Rules 22
CHAPTER 6 31
Performance Evaluation 31
Performance Evaluation and Clinical Evidence table 32
Performance Evaluation report checklist 34
CHAPTER 7 53
Conformity Assessment Route &Annexes 53
Table 1: Routes to conformity 54
Table 2: Annex requirement table 63
Table 3: Requirements for Annex IX Section 5 67
Table 4: Quality Management System reference table 68
CHAPTER 8 69
QMS Tables 69
ISO 13485 to IVDR requirements table 69
IVDR Article TO ISO 13485 clause table 75
IVDR Annex TO ISO 13485 clause table 78
CHAPTER 9 81
Timelines 81
Visual Timeline 84
Table Timeline 85