IVDR Class C Generic Device Groups
(Class C, EDMN + IVP code)
| EDMN CODE | EDMN CODE TITLE | IVP CODE | IVP CODE TOPIC |
|---|---|---|---|
| W0101 | Clinical chemistry | IVP 3002 | Biochemistry |
| W0101 | Clinical chemistry | IVP 3013 | Spectroscopy |
| W0102 | Immunochemistry (immunology) | IVP 3001 | Agglutination |
| W0102 | Immunochemistry (immunology) | IVP 3007 | Immunoassays |
| W0103 | Haematology / Haemostasis / Immunohaematology / Histology / Cytology | IVP 3006 | Flow cytometry |
| W0103 | Haematology / Haemostasis / Immunohaematology / Histology / Cytology | IVP 3007 | Immunoassays |
| W0104 | Microbiology (culture) | IVP 3014 | Cell function |
| W0105 | Infectious immunology | IVP 3007 | Immunoassays |
| W0105 | Infectious immunology | IVP 3011 | NAT / NGS |
| W0106 | Genetic testing | IVP 3004 | Chromosomal analysis |
| W0106 | Genetic testing | IVP 3011 | NAT / NGS |
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