3 Meddev Solutions Limited (RAPS e-Book version)
Contents
CONTENTS
CHAPTER 1 1
Welcome 1
CHAPTER 2 2
Background to the MDR 2
CHAPTER 3 9
How to use this guidebook 9
CHAPTER 4 11
Compliance guide 11
CHAPTER 5 21
Device Classification 21
Classification Rules 21
Non-Invasive Devices 22
Invasive Devices 25
Active Devices 29
Special Rules 33
Device which are not Medical Devices 38
CHAPTER 6 39
Clinical Evaluation 39
CHAPTER 7 65
Conformity Assessment Route &Annexes 65
CHAPTER 8 83
QMS Tables 83
ISO 13485 to MDR requirements table 83
MDR ARTICLE TO ISO 13485 CLAUSE table 93
MDR Annex TO ISO 13485 CLAUSE table 96
CHAPTER 9 99
Timelines 99
Timelines from the MDR 99
Visual Timeline 103