Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life).

renenatasha

Involved In Discussions
#11
Great discussion, guys! :) I'm just curious...

Say if we don't indicate the "use-by" date (on the non-sterile medical device label) but instead we include the "date of manufacture (DoM)";

1) How can the user tell when the product is good / safe for use? [can't be infinite, right? :p]

2) Must the "DoM" be prominent on the label?

3) Can it be reflected on the LOT #, e.g. LOT 18/04/001 (for lot manufactured on 2018-04)?

Share your thought please. Thanks :)
 
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Mark Meer

Trusted Information Resource
#12
...
1) How can the user tell when the product is good / safe for use? [can't be infinite, right? :p]
Do you need to? What does your risk analysis of using beyond a certain time say? If there is indeed a hazard or potentially harmful situation, you can include a warning. ...however in this case I'd say it'd probably also be worth considering adding a use-by date.


2) Must the "DoM" be prominent on the label?
No more so than other labelling information, unless your risk analysis would indicate otherwise. Consider a hypothetical product for which use beyond a certain time may be catastrophic. I'd be prudent to make the relevant dates prominent to the user, no?

3) Can it be reflected on the LOT #, e.g. LOT 18/04/001 (for lot manufactured on 2018-04)?
Yes, at least according to European regulations.
The MDR says (Annex I, 23.2 (j)):
"23.2. Information on the label
The label shall bear all of the following particulars:
...
(j) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;"
 
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