Like other items such as food, medicines etc. shelf-life study is also needed to be performed for medical devices and also required by many regulations such as MDD/MDR, FDA 510k etc. that require medical device to be labelled with an expiry date. However, there are not many guidelines or standards available that guide manufacturers on how to carry out this study and establish shelf life for their medical devices. It is totally upon the manufacturer to come up with a reliable way to perform the study and establish suitable evidence that support the shelf-life claim.
Briefly speaking, shelf life is defined as: “The duration or time period in which the medical device remains suitable for its intended use and also retains the required safety and performance characteristics acclaimed with the said device”
Shelf-life or stability study is compulsory not only for medical devices but also for the packaging. In general, there are two ways to carry out this study:
- Real time aging
- Accelerate aging
It is important to note that both the studies are required to be performed simultaneously as these two support each other and provide stronger evidence for the shelf-life claim to be made.
Some key factors that may impact medical device shelf-life and are needed to be considered while performing the study are:
- Product Material
- Product Manufacturing Processes
- Product Intended Use
- Packaging
- Storage and transportation
- Sterilization
Each of these factors can affect the overall performance and safety of the device on their own and should be kept in mind along with other factors while carrying out the study.
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