Class B Device Categories (IVR Code)
Examples for Device Categories (Class B, IVR code)
Excerpt from COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017:
| IVR 0605 | Devices intended to be used for monitoring of levels of medicinal products, substances or biological components |
| IVR 0606 | Devices intended to be used for non-infectious disease staging |
| IVR 0607 | Devices intended to be used for detection of pregnancy or fertility testing |
| IVR 0608 | Devices intended to be used for screening, determination or monitoring of physiological markers |
| IVR 0609 | Other devices intended to be used to define or monitor physiological status and therapeutic measures |
| IVR 0701 | Devices which are controls without a quantitative assigned value |
| IVR 0702 | Devices which are controls without a qualitative value |
How many technical documentation files are sampled by Notified Bodies
PRIOR TO CERTIFICATION
At least one device per generic device group and device category
DURING 1st CERTIFICATION CYCLE
5% of devices of each GDG or DC
At least one TD per year
At least one TD per year
DURING FOLLOWING CERTIFICATION CYCLES
15% of devices of each GDG or DC
At least one TD per year
At least one TD per year