Sterility expiration dating

14-Jun-2019 16:48

I wanted to gauge some feedback from you guys regarding Non-Sterile Class 1 Medical Device, we are acting as an intermediate and have started to see customer queries regarding expiry dates on a Non-Sterile Class 1 Medical Device.

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It is mostly a matter of device size and practicality.

Figure 1 shows, on the left, a sampling of items for which there was an expiration date (according to their packaging), while those on the right are selected items without an expiration date.

Of interest is the apparent lack of logic dictating expiration versus no expiration.

I’d venture a guess that small devices that go inside the oral cavity don’t need labelling (expiry or otherwise) on the device itself, but that’s pending a serious review by someone who knows exactly what the device is and what the intended use is.

In general the responses from rob73 and pkost are good.

It is mostly a matter of device size and practicality.

Figure 1 shows, on the left, a sampling of items for which there was an expiration date (according to their packaging), while those on the right are selected items without an expiration date.

Of interest is the apparent lack of logic dictating expiration versus no expiration.

I’d venture a guess that small devices that go inside the oral cavity don’t need labelling (expiry or otherwise) on the device itself, but that’s pending a serious review by someone who knows exactly what the device is and what the intended use is.

In general the responses from rob73 and pkost are good.

Rob's quote above is correct in that if it is appropriate, it should indicated, I don't however quite agree with it being hard to justify not using one.