Shipping Stability for Class III IVD (Non Sterile) Medical Device

[redknight07]

Greetings guys,

I have been working on shipping stability study protocol for class III IVD (HIV Rapid Test Device). Could you help me with the existing standards that exist which determine what testing needs to be performed to evaluate the tolerance of product to unanticipated shipping conditions? Thank you.

I am using " Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/SG1/N063:2011" as a reference document and this states that Shipping studies can be done under real and/or stimulated conditions and should include variable shipping conditions such as extreme heat/cold.

Can such a study be performed in house?

I am assuming that there is a standards which would be dealing with what needs to be covered in such a study. Can anybody shed some light on this? Thank you.

Best,
Aniket

 

[Ronen E]

Hi,

1) Yes, in my opinion such tests can be done in house.
2) Where are you exporting the device to? The applicable requirements might vary between domains.
3) Have you sifted through the harmonised standards list of the IVDDD?
4) Maybe try here: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html Look under "Stability" (the 1st header).
5) Look at the bottom of this page for Elsmar Cove threads that might be relevant.

Cheers,
Ronen.

 

[redknight07]

Thank you Ronen, I will go through those links and see how it applies to our product. We are planning to export the device to Asian and African countries after the relevant approval procedures.

Cheers,
Aniket

 

[Ronen E]

Hi,

I recommend having a very thorough understanding of the regulations that actually apply, before setting off. Some Asian and African countries have very low requirements, while STED represents a rather high standard, generally in line with the EC / Australian system (and now also "pseudo-harmonised" with some other countries, rather on the leading edge of international regulation).

Cheers,
Ronen.

 

[Quality Julie]

Are you marketing your product in just the US? Or in the EU as well. EN ISO 23640:2013 - In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents is the standard for products being sold in the EU.

 

[lynchoid]

It has been some time since you posted this, but I didn't see this in the responses. If your IVD is shipping refrigerated, ISTA 7E is a valuable standard. It recently replaced ISTA 5B. I have attached a descriptive document about ISTA 7E and the corresponding standard 20.

 

[HAMEDD]

How to perform stability study of Non sterile active medical device?

 

[Ronen E]

How to perform stability study of Non sterile active medical device?

Hello HAMEDD and welcome to the Cove

It's almost impossible to answer this questions without any details about the device. Generally, the goal is to show that the device will confidently meet all applicable requirements (design inputs) after spending its shelf life and use life (as defined by the manufacturer) under the anticipated / specified conditions, environmental and otherwise.

Cheers,
Ronen.