Where to place CE/label in Sterile IVD

#1
Hello,

I have an in-vitro diagnostic "test" that is to be supplied sterile. The "test" is placed inside a pouch and this sealed pouch containing the test is sterilised. The test is intended to be supplied in a "sales box" containing a number of pouches.

Notes on usage: when the test is used (by healthcare professionals), the user opens the pouch, removes the test from the pouch, fills the test with the human specimen to be analysed, waits for the result to be displayed and when completed disposes off the test into the clinical waste.

Essential requirement 8.1 of IVD (Directive 98/79/EC) says:
"As far as practicable and appropriate, the information needed to use the device safely and properly must be set out on the device itself and/or, where appropriate, on the sales packaging."
Additionally, article 16 of the directives says:
"The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, [...]"

I understand the label requirements for the sales box and other possible outer packaging but I am lookig for clarification on the following:
1. whether "device" in the text (both paragraphs) quoted above refers to (or can refer to) the pouch and contents as a single entity and the "device label", with the CE marking, can be placed only on the pouch and not on the test itself.​
2. if the label has to be placed both in the test and the pouch, whether the symbol "Sterile" should be removed from the label on the test and appear only on the pouch label (once the pouch is opened there is no guarantee that the test is sterile).​
Can anyone help? Any views?

Thank you!
 
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#2
Hi there, the harmonised standards for labelling and information to be supplied are your best bets here: ISO15223 and ISO 18113.

ISO18113 (I can't remember which part relates to sterile devices) will give you the best indication of what to include on your labels and Annex X of directive 98/79/EC will give you the specifics of the CE mark itself.
In answer to your specific questions above:

1. This it made clearer within the ISO18113 standard and breaks it down into immediate container label (what I gather is the "test") and outer container (which I gather is the "pouch). The specific elements of each are clear within the ISO18113 and the symbols required on each are listed within ISO15223.​
2. All sterile symbol requirements are listed within section 5.2 of the ISO15223 standard. Some symbols have to appear on both inner and outer container labels and some can appear on one or the other (depends on the size of the label also, which is a stipulation on the inner container label within ISO18113 (part 2 at least).​
Hopefully that helps, but you should really include these harmonised standards within your ER assessment.
 
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