| Theme | Summary of safety and performance (SSP) |
| Target Audience | Manufacturer |
| Products concerned | Class C and D IVD |
| Documents mentioned |
Regulation (EU) 2017/746 |
This guidance presents the model of the summary of safety and performance (SSP). This one must be established by manufacturers of class C and D devices, validated by a notified body and made available in EUDAMED.
For devices that are not intended for self-testing, the SSP must include a section dedicated to the professional user and, if necessary, a section dedicated to patients. It should be written in a way that is clear to the lay persons. An SSP model for this type of device is presented in Part 1.
If the device is intended for self-testing, the SSP should be written in a way that is clear to patients. An SSP model is presented in Section 2.