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,
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,