On-going stability study requirement for medical device


Our product is a consumable with two years shelf life and it is Class II medical device. I am looking for guidelines for on-going stability study for medical device after the product is launched. Your help is really appreciated.


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Unlike pharmaceuticals, there is no requirement to perform continued stability studies once a medical device is marketed. You are normally expected to have a minimum of accelerated shelf-life data, followed up with real-time data being generated. This validation is a once-off exercise, unless changes occur.
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