Shelf Life of Combination Sets for Class II Medical Devices

M

Mor628

Dear Cover's,

One of our medical device is a combination set (Foley Catheter + Syringe).

The label on the product which is packaged into one, says that the expiry of product (catheter + syringe) is 3 years. As the syringe is limited to 3 years, hence as a whole the product has a shelf life of 3 years.

However, below the expiration date we want to include a small note saying, that the catheter has 5 years of shelf life. Implying that the catheter is still safe to use once the syringe has expired.

I understand that one device, no matter how many combinations, can not have more than one expiration date. Does including the note, make it two expiration dates?

Are we breaking any regulations by doing so?
 

pkost

Trusted Information Resource
In the EU it *may* be possible, but it won't be liked, you would have an uphill battle with the notified body.

From a risk point of view it is extremely likely to cause confusion and may result in an expired syringe being used.

I wouldn't recommend this
 

Statistical Steven

Statistician
Leader
Super Moderator
I am not a regulatory expert, but does the catheter have to be used with the syringe? Is the kit a secondary packaging (the syringe and catheter have their own packaging). I have seen kit manufacturers put an expiry of the kit, but that is more a function of the packaging and shortest expiry of a compoent. If the components are "kitted" the individual components have their own expiry date, then I believe you can still use the catheter after 3 years by itself.

Dear Cover's,

One of our medical device is a combination set (Foley Catheter + Syringe).

The label on the product which is packaged into one, says that the expiry of product (catheter + syringe) is 3 years. As the syringe is limited to 3 years, hence as a whole the product has a shelf life of 3 years.

However, below the expiration date we want to include a small note saying, that the catheter has 5 years of shelf life. Implying that the catheter is still safe to use once the syringe has expired.

I understand that one device, no matter how many combinations, can not have more than one expiration date. Does including the note, make it two expiration dates?

Are we breaking any regulations by doing so?
 
M

Mor628

I am not a regulatory expert, but does the catheter have to be used with the syringe? Is the kit a secondary packaging (the syringe and catheter have their own packaging). I have seen kit manufacturers put an expiry of the kit, but that is more a function of the packaging and shortest expiry of a compoent. If the components are "kitted" the individual components have their own expiry date, then I believe you can still use the catheter after 3 years by itself.
No, it doesn't HAVE to be used with the catheter. Its functional individually as well.
Yup, the kit is a secondary packaging.
I suppose it depends to where we plan to sell it. Probably harder in the EU.
 
M

Mor628

Hi guys,
This is what the label looks like. I'm guessing it wont be received well ??
 

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