Dear All,
A quick consultation.
Long time ago our EU NB advised us during a submission of a new device class IIB that we amend the intended users section in the IFU from:
Intended users: Healthcare professionals
To:
Intended users: Healthcare professionals (Doctors or Nurses)
Meaning to add Dr and nurses.
We are now facing some RA difficulties in countries out of the EU requesting to omit Dr and Nursed.
My questions:
1. Is there any RA ground in written which backs us adding doctors and nurses, or was it a specific auditor exaggeration?
2. Should there is no legal claim within MDD to such addition, would we be required to notify the NB on such change, especially when it came from them?
Just trying to understand the logic behind it.
Thanks
Udi
A quick consultation.
Long time ago our EU NB advised us during a submission of a new device class IIB that we amend the intended users section in the IFU from:
Intended users: Healthcare professionals
To:
Intended users: Healthcare professionals (Doctors or Nurses)
Meaning to add Dr and nurses.
We are now facing some RA difficulties in countries out of the EU requesting to omit Dr and Nursed.
My questions:
1. Is there any RA ground in written which backs us adding doctors and nurses, or was it a specific auditor exaggeration?
2. Should there is no legal claim within MDD to such addition, would we be required to notify the NB on such change, especially when it came from them?
Just trying to understand the logic behind it.
Thanks
Udi