Dear all,
I anticipate that I am no expert of shelf life studies. I am just wondering, how it is possible to demonstrate shelf life of non-sterile products, or if a study is at all necessary for all devices. For example, for stainless steel accessories I expect that an analysis of the materials properties, design, and maybe literature studies would be enough to support the defined shelf-life. Or, for an active medical devices with incorporated functionality test before use a shelf life demonstration is really not needed at all.
On a different note, in my opinion, this is also linked to the packaging requirement in MDR, i.e. "to assure that packaging maintains the integrity and cleanliness of the product". Integrity of the product is linked to the ability of the product to perform its function, and this is a shelf life issue. Do we need to demonstrate that packaging is able to maintain the integrity and cleanliness for the whole shelf life period? Are packaging testing (ISTA) enough to prove the packaging suitability for the shelf life duration? We have a PMS history of course, and no complaints ever came back to us on this topic. So maybe this is already a demonstration.
What kind of plan can I put forward to comply with MDR requirements? Is there an official guideline or a good practice around?
Thank you in advance
Christian
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Christian Micheletti
Project Manager; Regulatory Affairs expert
Nouvag AG
Zurich
Switzerland
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