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Use By and Expiration Date for a Class 3 Medical Device in Europe

D

DesiQE

#1
Hi All,

Once again, I turn to you.

I was auditing a potential supplier in Europe for a Class 3 medical device and found this. The product has CE approval.

They have one year shelf life for the product that I was auditing.

They show manufacturing in July 2014 and Expiry (use by date) of July 2015. To my knowledge, this is not valid. I remember reading somewhere that if the use-by-date is given in month-year, then it should be assumed that the product was made in the beginning of the month and then given the shelf life. So that would mean, in this case, the expiry date should be June 2015. Only, if they give the full date dd-mm-yyyy, then they can use the same month. As in Manufacturing date: 25.07.2014 Expiry date: 24.07.2015.

Can you help me figure out where I might find this.

:thanx: in advance.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Hi All,

Once again, I turn to you.

I was auditing a potential supplier in Europe for a Class 3 medical device and found this. The product has CE approval.

They have one year shelf life for the product that I was auditing.

They show manufacturing in July 2014 and Expiry (use by date) of July 2015. To my knowledge, this is not valid. I remember reading somewhere that if the use-by-date is given in month-year, then it should be assumed that the product was made in the beginning of the month and then given the shelf life. So that would mean, in this case, the expiry date should be June 2015. Only, if they give the full date dd-mm-yyyy, then they can use the same month. As in Manufacturing date: 25.07.2014 Expiry date: 24.07.2015.

Can you help me figure out where I might find this.

:thanx: in advance.
Hi,

IMO you are right and don't need to "find this" anywhere. It's just good common sense. You can ask them what safeguards are in place that the device will not be used after >12 months.

Cheers,
Ronen.
 
D

DesiQE

#3
Hi Ronen,

As the saying goes "Common sense is not so common"! I am coming across these multiple issues related to the shelf life and dating of the product as you will see from my recent posts. Since these are not "written" anywhere, it is my sense versus their non-sense. And, when this has been going on unchecked by customers, or NBs, they feel like what they are doing is right. So, I am trying to find documented requirements that they can't defy as easily.
 
#4
Did you check how they qualified the 1 year shelf life? Maybe they actually have data to show stability of more than 1 year? Like maybe the protocol said to age the samples for 13 months because they want to label it the way they do?
 
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