Using STERILE symbols on outside and inside packaging

[mscottf]

My company is developing a medical device that has already attained CE Mark and our first surveillance audit is coming soon. Our product is actually a system of 4 devices, 3 or which are sterilized, one with EtO and two with E-beam radiation.

The inner pouch that holds the item with EtO has a lot information label that includes the STERILE-EO symbol. The 2 radiated items are sealed in a tray and then two trays and 2 pouches are packed into a 2-Pack box. The non-sterilized item remains in its own box. Presently, another lot information label is printed twice and one is applied to the inner tray and one is applied to the outside of the box. This label has only a generic STERILE label which is fine for the outside of the box, but I am concerned whether the auditor might feel that the label on the inner tray should be different and be the STERILE-R label. They passed this the first time, but the auditor is different this time.

What does the regulation say about this? Do we need to create a separate label for the inner tray that uses the STERILE-R symbol?

Thank you, Scott

 

[MIREGMGR]

I guess I'm unclear on how the outer label--on a box containing four devices, i.e. two sets of (pouch object + tray object)--functionally can have the same description-information as the tray label, which is on a package comprising one device.

If the products were under my control, we would have separate labels for the trays and the outer boxes to resolve the above issue; all STERILE indications on single-device labels would include an indication of method; and the system or multi-pack labels would include a list of contents, with separate method indications for the different items.

To answer your direct question, I'd guess that your auditor might gig you on this per MDD Annex I, Section 13.3(m), which is expressed as "must".