EU MDR Ramifications for no expiration date on labeling

L

Leigh76

Registered
#1
#1
We have a Class I non-sterile device which has only the date of manufacture on the label, no expiration date. For EU MDR I understand that where there is no indication of an expiration date, until which the medical device may be used safely, the date of manufacture must be present on the label. However, as a manufacturer, we have some customers pushing for an expiration date or useful life to be added to the labeling. Are there any EU MDR ramifications to NOT adding an expiration date to such products?

Thanks in advance!
 
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B

Billy Milly

Involved In Discussions
#2
#2
I find it hard to believe that the product in question has an infinite lifetime. You probably performed some kind of stability testing, which lasted for a known period of time. Therefore, your shelf life is defined (by you) and should be labelled to allow safe use...
 
Edward Reesor

Edward Reesor

Trusted Information Resource
#3
#3
Have a similar question: Assuming you have validity tests, is it satisfactory to state "Shelf life 3 years" beside the date of manufacture or does it mandate the date format with symbol? What is the reference for this (EU MDR specific)?
 
J

Junn1992

Involved In Discussions
#5
#5
Under 23.4 N)
if the device is reusable, .... Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;
 
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