Thank you! this is in alignment with what I started to do...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! 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).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.
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.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,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.