Where to place label for an IVD test?

[HarKor]

Hi,
I work for a company where we test patient samples using IVD test. Patient report containing the results is sent to the clinicians. My question is regarding label requirements. I have generated a label that has all the necessary information from IVDR Annex 1, Chapter II (20.2). I need help clarifying some requirements;

• What does date of manufacture mean?

At our company, people think that each time a sample is run, it is the date of manufacturing. I am of different opinion. I think that the device is already manufactured once design and development was completed and we got the approval. Therefore, date of manufacturing should not change every time a new sample is run.

• Where should we include the label?

Since we don't manufacturing any reagents or kits, we don't have a physical label. Is it ok to create a label and then store electronically and may be, even attach to each patient report?

Thank you so much!

 

[AngelRose]

When we talk about the “date of manufacture” under IVDR, this normally refers to when the device itself is made available for use. For example, in the case of a software as a medical device (SaMD), this would typically correspond to the software release date or to its last significant update. It would not change each time a patient sample is analysed or a report is generated.

As for the second question, it really depends on the nature of the IVD. If there is somehow a physical device or kit, the labelling information must be associated with that physical item and cannot exist only electronically or much less in the patient report. For the same SaMD, a controlled electronic label linked to the device documentation is generally acceptable, while the patient report should only reference the test or software version used.