Summary of Safety and Performance (SSP)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (EUDAMED).

 

No.

Brand Names

In-house model name

1

RIGHTEST Blood Glucose Monitoring System GM550

GM550

2

LineaD Blood Glucose Monitoring System EVO

3

mylife Pura Blood Glucose Monitoring System

4

mylife Pura X Blood Glucose Monitoring System

5

CLICKS Bionime Blood Glucose Monitoring System GM550

6

GE Blood Glucose Monitoring System GM550