EU Shelf life claims for individual materials

KMac

Registered
#1
Hi all,

For a sterile packaged medical device under the MDR, I am wondering whether a justification for aging can be used for EU shelf life claims if the individual materials of the product are tested (accelerated/real time aging), as opposed to the final product when the materials have undergone further processing steps?

Thanks,
 
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shimonv

Trusted Information Resource
#2
When individual materials go through manufacturing processes their characteristics often change, and thus a justification bases on the individual materials is no longer valid. Only in rare cases where the production process is so plain and clean you can make a case for it, but I wouldn't risk it with EU notified bodies.
 

chris1price

Trusted Information Resource
#3
I agree with Shimonv, also remember, frequently its not the product that is at issue, but the packaging providing the protection for the product that will degrade first.
 
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