UDI - Where to document it?

#1
Hello.
Wondering where the best way/place to incorporate the UDI requirement. New stand alone SOP, integrate it into design controls? Any constructive feedback is appreciated.
 
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yodon

Staff member
Super Moderator
#2
I'm a "minimalist" when it comes to SOPs so I would not have an SOP. My Design Controls SOP just say that labeling will comply with applicable regulations where the product is distributed. This is a product-specific thing and drives labeling requirements so I just incorporate into the (product) Development Plan.
 

mihzago

Trusted Information Resource
#3
I have a procedure I call "Design of Labeling", which contains a bunch of labeling specific requirements, and now also UDI.

I've seen some consultants list a UDI procedure as being required (typically in reference to EU MDR requirements), but in my opinion it does not have to be a stand-alone procedure, and I don't think there's a specific requirement for one.
You could probably also include it within a Design Control SOP as yodon alluded.
 
#4
I'm a "minimalist" when it comes to SOPs so I would not have an SOP. My Design Controls SOP just say that labeling will comply with applicable regulations where the product is distributed. This is a product-specific thing and drives labeling requirements so I just incorporate into the (product) Development Plan.
Thank you! this is in alignment with what I started to do...
 
#5
I have a procedure I call "Design of Labeling", which contains a bunch of labeling specific requirements, and now also UDI.

I've seen some consultants list a UDI procedure as being required (typically in reference to EU MDR requirements), but in my opinion it does not have to be a stand-alone procedure, and I don't think there's a specific requirement for one.
You could probably also include it within a Design Control SOP as yodon alluded.
Thank you! Yes- we have a labeling and artwork SOP, and a Lot of Control and Serialization SOP. in the latter I plan to reference the UDI Requirements for FDA and EU MDR and make a deliverable in Design controls SOP (design output).

Thank you both for the help and professional bounce. :-]
 

twanmul

Involved In Discussions
#6
We use a label specification document which outlines all of the requisites of the label, including size, material, adhesive and contents etc. for different devices. The UDI (and its sub-components) will most likely be added under its own section but the suggestions above would work equally well.
 
#7
We use a label specification document which outlines all of the requisites of the label, including size, material, adhesive and contents etc. for different devices. The UDI (and its sub-components) will most likely be added under its own section but the suggestions above would work equally well.
We are using a sample submission form, where the sample of printed part/label showing the layout and complete details specification of the printing, for the customer approval.
 

mpfizer

Involved In Discussions
#9
We use a label specification document which outlines all of the requisites of the label, including size, material, adhesive and contents etc. for different devices. The UDI (and its sub-components) will most likely be added under its own section but the suggestions above would work equally well.
Hi,

would be interested in the specifications of material , adhesive , printing inks used and tests conducted if any on label if you are willing to share .
Thanks
michelle
 
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