Intended Users in IFU (Instructions for Use)

Udirn1

Starting to get Involved
#1
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
 
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chris1price

Trusted Information Resource
#3
Difficult to say without knowing the reason the NB made the original recommendation. I have not come across any regulatory reason for adding "Doctors or Nurses". The usual issue concerns how the device is prescribed and who can use it. Suggesting a change to prescription use only (ie RX Only) might be a middle ground.
 

twanmul

Involved In Discussions
#5
It's also difficult to know as we don't know the type of device you're talking about as well as the reason why others are wanting the specific removed. Was this prompted by something within your user profiles or usability assessments?
I would say section 23.4 of MDR Annex I of the EU MDR is your best place to start. I'm not familiar with medical device IFU harmonised standards (I work with IVD's) but I assume you've done a review of the relevant standards as part of your ER/GSPR assessments and haven't found anything there?
 

Sicco

Involved In Discussions
#6
Hi Udirn,
When it comes to registration outside the EU, it depends on the local registration/competent authority if they allow you to change the intended purpose and omit the words doctors and nurses, if you make this change for units that will be available outside the EU I see no reason to report this change to your notified body (it is outside its EU "jurisdiction"), but in the event of such a change, I would only consider removing the CE mark from the labeling.
 
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