Table 2 Overview of the specific intended use items for all products and per product type and level of certification
Intended use item | |||||||
|---|---|---|---|---|---|---|---|
Medical indication/disease targeted | Part of the body or type of tissue | Use environment | User profile | Patient population | Operating principle | Total number of products | |
Total | 89 (64%) | 115 (83%) | 24 (17%) | 81 (58%) | 29 (21%) | 116 (83%) | 139 |
Regulatory class | |||||||
MDD, class I | 45 (87%) | 46 (88%) | 6 (12%) | 31 (60%) | 8 (15%) | 46 (88%) | 52 |
MDD, class IIa | 27 (49%) | 42 (76%) | 12 (22%) | 27 (49%) | 11 (20%) | 47 (85%) | 55 |
MDR, class IIa | 13 (57%) | 20 (87%) | 6 (26%) | 18 (78%) | 8 (35%) | 15 (65%) | 23 |
MDR, class IIb | 4 (44%) | 7 (78%) | 0 (0%) | 5 (56%) | 2 (22%) | 8 (89%) | 9 |
Product function | |||||||
Quantification | 28 (52%) | 46 (85%) | 8 (15%) | 23 (43%) | 8 (15%) | 45 (83%) | 54 |
Detection | 21 (58%) | 24 (67%) | 7 (19%) | 20 (56%) | 7 (19%) | 30 (83%) | 36 |
Diagnosis | 18 (72%) | 23 (92%) | 6 (24%) | 17 (68%) | 8 (32%) | 18 (72%) | 25 |
Triage | 17 (94%) | 17 (94%) | 3 (17%) | 17 (94%) | 2 (11%) | 18 (100%) | 18 |
Image enhancement | 5 (83%) | 5 (83%) | 0 (0%) | 4 (67%) | 4 (67%) | 5 (83%) | 6 |