Software as a Medical Device
Second Edition
vii Regulatory Affairs Professionals Society
Preface ...........................................................................................................................................................................iii
Author Acknowledgments. ...............................................................................................................................................v
Chapter 1: Introduction. ..................................................................................................................................................1
Koen Cobbaert, MSc, and Gert Bos, PhD, MSc, FRAPS
Chapter 2: Software as a Medical Device. ..........................................................................................................................5
Pat Baird, MSc, MBA Koen Cobbaert, MSc Zhuo Li, MSc
Introduction. .....................................................................................................................................................................................5
SaMD Versus SiMD.........................................................................................................................................................................5
SaMD for Population Health............................................................................................................................................................6
SaMD in the US. ..............................................................................................................................................................................6
SaMD in Canada. .............................................................................................................................................................................7
MDSW in the EU. ...........................................................................................................................................................................7
SaMD in China.................................................................................................................................................................................8
Modules.............................................................................................................................................................................................9
Wearables. .......................................................................................................................................................................................10
Scenario 1: Wearable and Software Are an Integral Part of a Medical Device...........................................................................11
Scenario 2: Wearable Is an Accessory for SaMD/MDSW.........................................................................................................11
Scenario 3: Software Is an Accessory for a Medical Device Wearable.......................................................................................12
Scenario 4: Only Software Is a Medical Device, Wearable Not Subject to Regulation. .............................................................12
Scenario 5: Wearable and Software Are Placed on the Market as a System...............................................................................13
Conclusion. .....................................................................................................................................................................................13
Chapter 3: Software as an IVD Medical Device. ..............................................................................................................15
Christie Hughes, MPH, MLS(ASCP), RCC-IVDR, and Henk-Willem A. Mutsaers
Introduction. ...................................................................................................................................................................................15
Qualification of IVD Software as an IVD SaMD......................................................................................................................15
Qualification of IVD Software in the EU..................................................................................................................................15
Qualification of IVD Software in the US...................................................................................................................................17
Qualification of IVD Software in Canada..................................................................................................................................18
Defining the Intended Purpose for an IVD SaMD. .......................................................................................................................19
Constructing the Intended Use Statement ................................................................................................................................19
Identifying Claims and Benefits for the IVD SaMD ................................................................................................................21
IVD SaMD Classification...............................................................................................................................................................21
Classification of IVD SaMD in the US. ....................................................................................................................................21
Classification of IVD SaMD in Canada. ...................................................................................................................................24
Classification of IVD MDSW in the EU. .................................................................................................................................24
Artificial Intelligence and Machine Learning for IVDs ............................................................................................................25
Performance Evaluation and Clinical Evidence for IVD SaMD. ..............................................................................................25
Clinical Association of IVD SaMD. ..........................................................................................................................................26
Contents
Second Edition
vii Regulatory Affairs Professionals Society
Preface ...........................................................................................................................................................................iii
Author Acknowledgments. ...............................................................................................................................................v
Chapter 1: Introduction. ..................................................................................................................................................1
Koen Cobbaert, MSc, and Gert Bos, PhD, MSc, FRAPS
Chapter 2: Software as a Medical Device. ..........................................................................................................................5
Pat Baird, MSc, MBA Koen Cobbaert, MSc Zhuo Li, MSc
Introduction. .....................................................................................................................................................................................5
SaMD Versus SiMD.........................................................................................................................................................................5
SaMD for Population Health............................................................................................................................................................6
SaMD in the US. ..............................................................................................................................................................................6
SaMD in Canada. .............................................................................................................................................................................7
MDSW in the EU. ...........................................................................................................................................................................7
SaMD in China.................................................................................................................................................................................8
Modules.............................................................................................................................................................................................9
Wearables. .......................................................................................................................................................................................10
Scenario 1: Wearable and Software Are an Integral Part of a Medical Device...........................................................................11
Scenario 2: Wearable Is an Accessory for SaMD/MDSW.........................................................................................................11
Scenario 3: Software Is an Accessory for a Medical Device Wearable.......................................................................................12
Scenario 4: Only Software Is a Medical Device, Wearable Not Subject to Regulation. .............................................................12
Scenario 5: Wearable and Software Are Placed on the Market as a System...............................................................................13
Conclusion. .....................................................................................................................................................................................13
Chapter 3: Software as an IVD Medical Device. ..............................................................................................................15
Christie Hughes, MPH, MLS(ASCP), RCC-IVDR, and Henk-Willem A. Mutsaers
Introduction. ...................................................................................................................................................................................15
Qualification of IVD Software as an IVD SaMD......................................................................................................................15
Qualification of IVD Software in the EU..................................................................................................................................15
Qualification of IVD Software in the US...................................................................................................................................17
Qualification of IVD Software in Canada..................................................................................................................................18
Defining the Intended Purpose for an IVD SaMD. .......................................................................................................................19
Constructing the Intended Use Statement ................................................................................................................................19
Identifying Claims and Benefits for the IVD SaMD ................................................................................................................21
IVD SaMD Classification...............................................................................................................................................................21
Classification of IVD SaMD in the US. ....................................................................................................................................21
Classification of IVD SaMD in Canada. ...................................................................................................................................24
Classification of IVD MDSW in the EU. .................................................................................................................................24
Artificial Intelligence and Machine Learning for IVDs ............................................................................................................25
Performance Evaluation and Clinical Evidence for IVD SaMD. ..............................................................................................25
Clinical Association of IVD SaMD. ..........................................................................................................................................26
Contents