Labeling Requirements in Part A Class IIb Medical Device Technical File



Hello experts:

I am updating the labeling section of a class IIb technical file. Our company used to list the label part numbers in this section. These labels are device identity label bearing CE mark & manufacturer information, warning labels, labels with electrical symbols, etc. this practice makes our work very difficult because the old labels are obsolete and new labels are created frequently each time we launch new models in the newly registered countries within or beyond EU territory.

I am wondering if it is necessary to list every label part number in the labeling section and add or delete the label part numbers when changes are made.

A more specific example is that we just created a label with a power supply direction symbol next to the power supply connector. Because the label is new, the new label part number has to be included in the technical file per our current practice. This label has been reviewed by our CB scheme lab and included in the CB report, which is reference in the labeling section of the ER checklist.

The NB-Med for technical file and design dossier does not specify what kind of labels should be included in the technical file part A. So different person has his or her own interpretation. TUV's technical file guidance recommends using labeling examples to demonstrate compliance.

Can you let me know 1) if this perticular power suppli label needs to be listed in the technical file part A; 2) what is the common practice to meet the labeling requirements in technical file part A.

This ia a simple question, but takes quite a few words to explain clearly (maybe clear as mad?). Your time and help will be greatly appreciated.



Labeling on the device is a technical information to the user. It is also a regulatory information. Let us first understand that this is very important in the technical file.
Next is to link your current labels directory directly in the technical file, and let the file reviewer to be able to view the label and all its contents.
Do not duplicate the work. Instead in your labeling section, make a mention to an annex folder that shows up all labels concerned to the devices in the technical file and keep that folder live.

yana prus

Great advice from Somashekar. I usually make a reference in Part A to the Part B where main regulatory labels are detailed, and make another reference in Part A to DMR where all the labels are listed.
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