Software as a Medical Device
Second Edition
xiv Regulatory Affairs Professionals Society
Figure 10-5. Examples of Usability Roles and Responsibilities ....................................................................................................113
Figure 10-6. Example of a Process Representing Activities Related to User Experience Design .................................................114
Figure 10-7. Relationship Between User Needs, Usability-Sensitive User Needs, Use Scenarios, and Usability Goals ................115
Figure 10-8. Examples of User Interface Requirements................................................................................................................117
Figure 10-9. Example Table of Contents for a Template to Document User Observations .........................................................118
Figure 10-10. Example of a Walkthrough Evaluation ..................................................................................................................119
Figure 10-11. Walkthrough Example Involving a Scenario With Different Tasks .......................................................................120
Figure 10-12. Example of Usability Severity Scale........................................................................................................................122
Figure 10-13. Single Ease Question (SEQ) .................................................................................................................................124
Figure 10-14. Intuitive SUS Score Graph ....................................................................................................................................125
Figure 10-15. SUS Scale Interpretation. .......................................................................................................................................125
Figure 11-1. A Simplified Diagram of Different AI Techniques..................................................................................................132
Figure 11-2. Countries Adhering to AI Principles........................................................................................................................134
Figure 11-3. Scheme with Criteria and Examples to Qualify Software as an AI System..............................................................135
Figure 11-4. Global and Local Model Change ............................................................................................................................136
Figure 11-5. Visualization of Federated Learning.........................................................................................................................137
Figure 11-6. AI-based Medical Devices........................................................................................................................................138
Figure 11-7. Overview of NMPA Guidelines and Standardization Applicable to AI-based Medical Devices For
Use in China............................................................................................................................................................................142
Figure 11-8. Visualization AI System Qualification and Classification .......................................................................................143
Figure 11-9. Boolean representation of AIA Article 6.3 exemption criteria. ................................................................................144
Figure 11-10. Decision Tree for Biometric Categorization System Qualification.........................................................................145
Figure 11-11. Visualization of AIA Stakeholders. ........................................................................................................................146
Figure 12-1. CEN ISO/TS 82304-2:2021 Health App Quality Label.................................................................................152
Figure 13-1. The Relationship Between Different Types of Data..................................................................................................156
Figure 13-2. The Primary Data Lifecycle. .....................................................................................................................................157
Figure 13-3. A Schematic Classification of Legislation Affecting Data........................................................................................163
Figure 13-4. A Schematic Representation of the Relationship Between the Data Act, the Data Governance Act, and
the EHDS. ...............................................................................................................................................................................164
Figure 13-5. Schematic Representation of Data Processing Agreements......................................................................................165
Figure 13-6. Schematic Representation of an EU Controller Contracting a Non-EU-Based Processor, *in a Country
Where No Adequacy Decision Is in Place (DPA +SCC)........................................................................................................165
Figure 13-7. Example Relationship Between Covered Entities and Business Associate Agreements (Where SAAS Refers to
Software as a Service)...............................................................................................................................................................167
Figure 13-8. (A) Simplified Overview of the Plan-Do-Check-Act Cycle and How Data Are Used to Support a Quality
Management System (B) Specific Example Using Customer Feedback (Complaint) Data....................................................170
Figure 14-1. Hardware With Embedded Software. ......................................................................................................................184
Figure 14-2. Separate Hardware and Software Integrated at Installation. ....................................................................................185
Figure 14-3. Independent Software (Software-Only Offering).....................................................................................................186
Figure 14-4. Visualization of Economic Operators and Their Interactions Under the Union Harmonized Legislation...............187
Figure 14-5. Clinical Investigation Governance for a Third-Country Manufacturer’s Investigational Device Not Yet Placed
on the Union Market................................................................................................................................................................190
Figure 14-6. Measures for Consideration Under MDCG 2025-4 ...............................................................................................197
Tables
Table 3-1. Relevant Definitions in Canada. ....................................................................................................................................19
Table 3-2. Example of Intended Use Element Breakdown. ............................................................................................................20
Table 3-3. Example of Claims and Benefits List. ............................................................................................................................21
Table 3-4. FDA Device Risk Classifications. ..................................................................................................................................22
Table 3-5. AI Act Classification Rules for High-Risk IVD AI Systems (MDAI)..........................................................................25
Table 4-1. Translation of the Software Categories in the Software Chapter 21 of China’s NMPA’s National Medical
Products......................................................................................................................................................................................33
Table 4-2. The Type and Frequency of Reporting to Competent Authorities Based on Risk Class in the EU. ..............................45
Table 5-1. Guidelines and Standards Relevant for the Generation of Clinical Evidence and Clinical Evaluation of SaMD. ........55
Table 6-1. Probability. .....................................................................................................................................................................62
Table 6-2. Qualitative and Semiqualitative Probability. ..................................................................................................................62
Table 6-3. Example Severity Scale..................................................................................................................................................62
Second Edition
xiv Regulatory Affairs Professionals Society
Figure 10-5. Examples of Usability Roles and Responsibilities ....................................................................................................113
Figure 10-6. Example of a Process Representing Activities Related to User Experience Design .................................................114
Figure 10-7. Relationship Between User Needs, Usability-Sensitive User Needs, Use Scenarios, and Usability Goals ................115
Figure 10-8. Examples of User Interface Requirements................................................................................................................117
Figure 10-9. Example Table of Contents for a Template to Document User Observations .........................................................118
Figure 10-10. Example of a Walkthrough Evaluation ..................................................................................................................119
Figure 10-11. Walkthrough Example Involving a Scenario With Different Tasks .......................................................................120
Figure 10-12. Example of Usability Severity Scale........................................................................................................................122
Figure 10-13. Single Ease Question (SEQ) .................................................................................................................................124
Figure 10-14. Intuitive SUS Score Graph ....................................................................................................................................125
Figure 10-15. SUS Scale Interpretation. .......................................................................................................................................125
Figure 11-1. A Simplified Diagram of Different AI Techniques..................................................................................................132
Figure 11-2. Countries Adhering to AI Principles........................................................................................................................134
Figure 11-3. Scheme with Criteria and Examples to Qualify Software as an AI System..............................................................135
Figure 11-4. Global and Local Model Change ............................................................................................................................136
Figure 11-5. Visualization of Federated Learning.........................................................................................................................137
Figure 11-6. AI-based Medical Devices........................................................................................................................................138
Figure 11-7. Overview of NMPA Guidelines and Standardization Applicable to AI-based Medical Devices For
Use in China............................................................................................................................................................................142
Figure 11-8. Visualization AI System Qualification and Classification .......................................................................................143
Figure 11-9. Boolean representation of AIA Article 6.3 exemption criteria. ................................................................................144
Figure 11-10. Decision Tree for Biometric Categorization System Qualification.........................................................................145
Figure 11-11. Visualization of AIA Stakeholders. ........................................................................................................................146
Figure 12-1. CEN ISO/TS 82304-2:2021 Health App Quality Label.................................................................................152
Figure 13-1. The Relationship Between Different Types of Data..................................................................................................156
Figure 13-2. The Primary Data Lifecycle. .....................................................................................................................................157
Figure 13-3. A Schematic Classification of Legislation Affecting Data........................................................................................163
Figure 13-4. A Schematic Representation of the Relationship Between the Data Act, the Data Governance Act, and
the EHDS. ...............................................................................................................................................................................164
Figure 13-5. Schematic Representation of Data Processing Agreements......................................................................................165
Figure 13-6. Schematic Representation of an EU Controller Contracting a Non-EU-Based Processor, *in a Country
Where No Adequacy Decision Is in Place (DPA +SCC)........................................................................................................165
Figure 13-7. Example Relationship Between Covered Entities and Business Associate Agreements (Where SAAS Refers to
Software as a Service)...............................................................................................................................................................167
Figure 13-8. (A) Simplified Overview of the Plan-Do-Check-Act Cycle and How Data Are Used to Support a Quality
Management System (B) Specific Example Using Customer Feedback (Complaint) Data....................................................170
Figure 14-1. Hardware With Embedded Software. ......................................................................................................................184
Figure 14-2. Separate Hardware and Software Integrated at Installation. ....................................................................................185
Figure 14-3. Independent Software (Software-Only Offering).....................................................................................................186
Figure 14-4. Visualization of Economic Operators and Their Interactions Under the Union Harmonized Legislation...............187
Figure 14-5. Clinical Investigation Governance for a Third-Country Manufacturer’s Investigational Device Not Yet Placed
on the Union Market................................................................................................................................................................190
Figure 14-6. Measures for Consideration Under MDCG 2025-4 ...............................................................................................197
Tables
Table 3-1. Relevant Definitions in Canada. ....................................................................................................................................19
Table 3-2. Example of Intended Use Element Breakdown. ............................................................................................................20
Table 3-3. Example of Claims and Benefits List. ............................................................................................................................21
Table 3-4. FDA Device Risk Classifications. ..................................................................................................................................22
Table 3-5. AI Act Classification Rules for High-Risk IVD AI Systems (MDAI)..........................................................................25
Table 4-1. Translation of the Software Categories in the Software Chapter 21 of China’s NMPA’s National Medical
Products......................................................................................................................................................................................33
Table 4-2. The Type and Frequency of Reporting to Competent Authorities Based on Risk Class in the EU. ..............................45
Table 5-1. Guidelines and Standards Relevant for the Generation of Clinical Evidence and Clinical Evaluation of SaMD. ........55
Table 6-1. Probability. .....................................................................................................................................................................62
Table 6-2. Qualitative and Semiqualitative Probability. ..................................................................................................................62
Table 6-3. Example Severity Scale..................................................................................................................................................62