Question

Requirements and references

• GSPR 23

Documents reviewed by BSI

• ifu.pdf

Question 1: GSPR 23.1(a) compliance and corrective action 4

Compliance to GSPR 23.1(a) and effective implementation of corrective action 4 are not fully demonstrated because:

a. The sample label and instructions in installation instructions in the IFU, § User Interface do not meet the requirements of GSPR 23.2 (e.g., do not include the name of the device, UDI, date of manufacture, intended purpose, indication the device is a medical device, etc.)

b. The instructions do not require the installer to provide users a link to the eIFU website (e.g., via the user interface, training, email, etc.).

Please provide the location of this information or provide updated documentation if necessary.

BSI observation

It is also unclear why the installation instructions reference GSPR 17.1.