Software as a Medical Device
Second Edition
xv Regulatory Affairs Professionals Society
Table 6-4. Example Risk Matrix. ....................................................................................................................................................63
Table 6-5. Typical Hazards of In Vitro Diagnostic Software. .........................................................................................................63
Table 6-6. Example Software Risk Assessment...............................................................................................................................64
Table 6-7. Examples of Diagnosis and Factors to Consider in the Severity Assessment.................................................................66
Table 10-1. Examples of Usability Goals.......................................................................................................................................116
Table 10-2. Heuristics Report Example. .......................................................................................................................................121
Table 10-3. System Usability Score (SUS) ...................................................................................................................................124
Table 10-4. Acceptance Criteria Examples ...................................................................................................................................126
Table 11-1. Comparative Overview of Current AI Regulatory Policy. Simplified and based on the Centre d’Expertise
International de Montréal en Intelligence Artificielle (CEIMIA) Assessment.........................................................................131
Table 11-2. Various Definitions for AI Systems............................................................................................................................135
Table 11-3. FDA’s Components of a Predetermined Change Control Plan..................................................................................139
Table 13-1. Overview of Regulatory Requirements for DPO Appointment.................................................................................161
Table 13-2. Overview of Data Retention Periods..........................................................................................................................162
Table 13-3. Overview of Sections Addressing Data Regulations. .................................................................................................163
Table 13-4. Overview of Data Legislation. ...................................................................................................................................164
Table 13-5. Overview of data breach notification requirements. ...................................................................................................174
Table 14-1. Definition of Placement on the Market According to Various EU Legislations. ..........................................................180
Table 14-2. Definition of Making Available According to Various EU Legislations. ....................................................................181
Table 14-3. Definition of Putting Into Service According to Various EU Legislations. .................................................................181
Table 14-4. Definition of Manufacturer According to Various EU Legislations...........................................................................188
Table 14-5. Definition of Importer According to Various EU legislations. ....................................................................................188
Table 14-6. Definition of Distributor According to Various EU Legislations. ..............................................................................189
Table 14-7. Definition of Fulfillment Service Provider According to Various EU Legislations......................................................189
Table 14-8. Deployer Definition According to Various EU Legislations. .....................................................................................191
Table 14-9. Provider Definition According to Various EU Legislations. ......................................................................................191
Table 14-10. Definition of Intermediary Services According to Various EU Legislations. .............................................................192
Table 14-11. Definition of Online Platform According to Various EU Legislations. ...................................................................193
Table 14-12. Comparison of Importer Obligations Under the EU AIA and the EU MDR .......................................................194
Table 14-13. Comparison of Distributor Obligations Under the EU AIA and the EU MDR.....................................................195
Table 15-1. Digital Health Technologies Categorization and Impact...........................................................................................202
Table 15-2. Health Technology Assessment Core Model Framework (EUnetHTA). ..................................................................203
Table 15-3. EDiHTA Principles. ..................................................................................................................................................206
Second Edition
xv Regulatory Affairs Professionals Society
Table 6-4. Example Risk Matrix. ....................................................................................................................................................63
Table 6-5. Typical Hazards of In Vitro Diagnostic Software. .........................................................................................................63
Table 6-6. Example Software Risk Assessment...............................................................................................................................64
Table 6-7. Examples of Diagnosis and Factors to Consider in the Severity Assessment.................................................................66
Table 10-1. Examples of Usability Goals.......................................................................................................................................116
Table 10-2. Heuristics Report Example. .......................................................................................................................................121
Table 10-3. System Usability Score (SUS) ...................................................................................................................................124
Table 10-4. Acceptance Criteria Examples ...................................................................................................................................126
Table 11-1. Comparative Overview of Current AI Regulatory Policy. Simplified and based on the Centre d’Expertise
International de Montréal en Intelligence Artificielle (CEIMIA) Assessment.........................................................................131
Table 11-2. Various Definitions for AI Systems............................................................................................................................135
Table 11-3. FDA’s Components of a Predetermined Change Control Plan..................................................................................139
Table 13-1. Overview of Regulatory Requirements for DPO Appointment.................................................................................161
Table 13-2. Overview of Data Retention Periods..........................................................................................................................162
Table 13-3. Overview of Sections Addressing Data Regulations. .................................................................................................163
Table 13-4. Overview of Data Legislation. ...................................................................................................................................164
Table 13-5. Overview of data breach notification requirements. ...................................................................................................174
Table 14-1. Definition of Placement on the Market According to Various EU Legislations. ..........................................................180
Table 14-2. Definition of Making Available According to Various EU Legislations. ....................................................................181
Table 14-3. Definition of Putting Into Service According to Various EU Legislations. .................................................................181
Table 14-4. Definition of Manufacturer According to Various EU Legislations...........................................................................188
Table 14-5. Definition of Importer According to Various EU legislations. ....................................................................................188
Table 14-6. Definition of Distributor According to Various EU Legislations. ..............................................................................189
Table 14-7. Definition of Fulfillment Service Provider According to Various EU Legislations......................................................189
Table 14-8. Deployer Definition According to Various EU Legislations. .....................................................................................191
Table 14-9. Provider Definition According to Various EU Legislations. ......................................................................................191
Table 14-10. Definition of Intermediary Services According to Various EU Legislations. .............................................................192
Table 14-11. Definition of Online Platform According to Various EU Legislations. ...................................................................193
Table 14-12. Comparison of Importer Obligations Under the EU AIA and the EU MDR .......................................................194
Table 14-13. Comparison of Distributor Obligations Under the EU AIA and the EU MDR.....................................................195
Table 15-1. Digital Health Technologies Categorization and Impact...........................................................................................202
Table 15-2. Health Technology Assessment Core Model Framework (EUnetHTA). ..................................................................203
Table 15-3. EDiHTA Principles. ..................................................................................................................................................206