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Setting initial Expiry Date of an IVD per BS EN 23640:2015

anoia

Registered
#1
Setting initial expiry date of IVD as per BS EN 23640:2015

Apologies if this is the wrong place to post this, I'm a first time poster, but have found Elsmar Cove to be a valuable wealth of information over the years.

We're setting the initial expiry date for our self-test IVD for the purposes of CE marking to the IVDD and a debate has broken out about how to interpret BS EN 23640:2015 (the stability standard).

It says "Data from accelerated stability studies and/or experience gained with IVD reagents that can reasonably be expected to be comparable with regard to their stability characteristics may be taken into account for establishing initial expiry dating. Experience with similar reagents and the risk associated with the use of the device should be used to establish the basis for initial expiry dating."

Our device is equivalent to competitors already on the market with a shelf life. Can we use the devices already on the market from our competitors to justify our initial expiry date? We'll have some of the accelerated degradation study data back to include in the TF submission but not enough to cover the shelf life we want. The device is relatively low risk.

I'm loathed to ask our NB as whenever I ask them anything, all I get back is "I cant answer that as it might be classed as consultancy".

:thanx:
 
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yodon

Staff member
Super Moderator
#2
Welcome to the Cove! Can't let a first-time post go unanswered. This isn't my area but I'll put in my 2 cents to maybe get the discussion going.

From what you said, I don't think there's enough information to say whether you can adopt your competitor's shelf life for your product. I would think you'd have to demonstrate equivalence in processing and packaging.

I think it's pretty common to submit with just an initial expiration period and then, as your citation indicates, expand as you get data to justify.

Your NB should be able to tell you if your approach would be acceptable. They can't DEFINE the approach, though, as that would, indeed, be consulting. I realize the pendulum has swung and there may be a more 'conservative' approach to communications - but you might want to try and establish a dialog.
 
#3
Many thanks for the reply!

I've managed to convince senior management that we can go to market with an 18 month shelf life (competitors have 2 years) with the promise that if we get our accelerated degradation studies in order and they prove favourable, we can extend the shelf life as soon as possible.

Maybe it's the way I'm asking questions to the NB that always gets me an unhelpful answer. I'll try wording it more along the lines of "we're doing this, is it acceptable?" and see what happens. It's my first time dealing with this particular NB so I'm having to learn how to get helpful information from them.
 

yodon

Staff member
Super Moderator
#4
Be sure to have justification for the 18-month period. What I've normally seen for sterilized product is that 12 months is a typical initial period while accelerated life tests and actual life tests are underway.
 
E

EthanLoh

#5
Has your company conducted any accelerated studies?

If yes, that is acceptable for new product. However your company will need to conduct a real time study.

Normally, Notified Bodies will not answer such questions. Your company may need an external consultant.
 
K

Karen747

#6
Hi All,

I did a search and this seems to be the only thread related to BS EN 23640:2015, so apologies for piggybacking on the thread.

I wanted to ask a question about specimen stability, 23640 only specifies lots for "reagent" stability.

So I was wondering would you have to prove specimen stability through three lots or would one be acceptable?

Many thanks :):)
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Hi All,

I did a search and this seems to be the only thread related to BS EN 23640:2015, so apologies for piggybacking on the thread.

I wanted to ask a question about specimen stability, 23640 only specifies lots for "reagent" stability.

So I was wondering would you have to prove specimen stability through three lots or would one be acceptable?

Many thanks :):)
What do you mean by “specimen stability”? Why would specimens be kept for extended periods?

(Asking out of curiousity, IVD is not exactly my forte)
 
Last edited:
E

EthanLoh

#8
Hi Karen747,

May be you can consider CLSI - MM13 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods. There are storage temperature and duration for certain specimens defined in this document.

E.g. Plasma samples are stable for up to five days at 2 to 8 °C and longer if frozen at -20 °C or -70 °C or lower.

Alternative, you may wish to perform your own specimens stability study. There is no defined requirement on the number of lots.

Generally, you will need to prove the stability and reactivity of the specimens after a certain number of thaw and freeze cycles. Or after deep freezing at certain points, e.g. -20oC, -80oC, etc.

PS: The lab result is only as good as the sample.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Hi Karen747,

May be you can consider CLSI - MM13 - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods. There are storage temperature and duration for certain specimens defined in this document.

E.g. Plasma samples are stable for up to five days at 2 to 8 °C and longer if frozen at -20 °C or -70 °C or lower.

Alternative, you may wish to perform your own specimens stability study. There is no defined requirement on the number of lots.

Generally, you will need to prove the stability and reactivity of the specimens after a certain number of thaw and freeze cycles. Or after deep freezing at certain points, e.g. -20oC, -80oC, etc.

PS: The lab result is only as good as the sample.
Thanks for the great overview. I didn’t think of freezing/thawing :bonk:
 
K

Karen747

#10
What do you mean by “specimen stability”? Why would specimens be kept for extended periods?

(Asking out of curiousity, IVD is not exactly my forte)
Hi Ronen,

Stability of serum,plasma urine etc whatever is used with the IVD test, a hospital will normally not use up the fresh sample immediately and so the sample will be frozen or put into the fridge for future testing if necessary, on our IVD IFUs you would usually see X specimen is stable for 7 days refrigerated and/or frozen. (The time could be longer depending on the length of the study the manufacturer has performed)

I know you wouldn't get "lots" of specimens so I wasn't sure if there would still be a 3 lot requirement to test the specimen to prove stability for the claim on the IFU.


Alternative, you may wish to perform your own specimens stability study. There is no defined requirement on the number of lots.
EthanLoh thanks for clarifying my question on the lots!! There was a debate in the office whether there should be a specific amount of lots.
 
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