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".
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".