Product Lifetime on Labeling

Cthames

Involved In Discussions
Hello all,

I am working with a radiological medical device that currently has lifetime testing validation for one year. We note the lifetime of the product is one-year in the user manual. Does this information need to be on the adhesive label affixed to the product as well?

I know there is a distinction between product lifetime and shelf-life. My experience has primarily been expiration dates based upon how long a device is validated to remain sterile once packaged and sterilized.

I am having trouble finding information regarding when expiration date/end-of-life date is required for medical devices. I have referred to several FDA guidance documents as well as 21 CFR Part 801, and still can't find a clear answer.

Many thanks.
 

planB

Super Moderator
Cthames,

while probably not strictly applicable to your device, ISO 17664-1 and -2 contain some clauses you may want to take as a reference for your intended use - quote from ISO 17664-2:2021:

6.3 Limitations and restrictions on processing
6.3.1 If processing of a medical device in accordance with the medical device manufacturer’s instructions is known to lead to degradation that can limit the service life of the medical device, then the medical device manufacturer shall provide such information regarding limitations and restrictions to the processor.
6.3.2 If the service life of the medical device is limited by the number of processing cycles or some other end of life indicator(s) this information shall also be provided.

Whether you label your end-of-life information directly on your product might also be determined by the consequences / potential harm related to using an expired device.

HTH,
 

pziemlewicz

Involved In Discussions
I agree with @planB, but get there a little bit differently:

ISO 14969, clause 7.1.3
...basis of the defined lifetime of the medical device should be documented

IEC 60601-1, clause 1 requires lifetime be declared and documented, then clause 4.4 tells you to include this in the risk management file.

How does use past end of life rate in your HA? Since most of your device users won't have IFU at the ready, you should make sure the date is in their face if there is potential for harm. You could easily include the "use by" symbol with date as a part of your UDI.
 
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