Sterile Medical Device Package Development

When the development and validation of the packaging manufacturing process are completed, the standard testing procedures (e.g., ASTM) should be used to ensure sterile medical device package integrity and the sterility of the product after additional production processes. 

This chapter will provide a systematic and standard a [Hoach to developing a comprehensive package system that meets regulatory hurdles and ensures a high degree of confidence that the sterile medical device product will meet its perfoimance specifications at the point of end use. These elements include ... 

As previously noted, medical devices are developed and marketed under strict regulatory requirements to ensure safety and efficacy. The transcutaneous nature of the minimally invasive CGM systems on the market and in development creates additional requirements on the materials, processes, packaging, and delivery of the devices. In vitro diagnostic devices are considered to be a subclass of medical devices, and a separate EU regulation (98/79EC) applies. In contrast to in vitro diagnostic devices, medical devices need, e.g., a biocompatibility assessment, and for invasive sensors also sterilization, disinfection requirements apply. As such, the materials used in the constmction of the transcutaneous part of the sensor, and the complete sensor itself, must be biocompatible in the sense that the sensor exhibits no toxicity toward the surrounding tissue. 

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