6.7 Stability and shelf life documentation (MDR)
This section of the technical documentation provides evidence that the medical device maintains its safety, performance, and quality throughout its intended shelf life. Stability and shelf life data are essential for defining storage conditions, expiry dates, and ensuring compliance with MDR.
Stability testing strategy
Stability studies are designed to simulate real-time and accelerated storage conditions. These tests evaluate the impact of environmental factors such as temperature, humidity, and light on the physical, chemical, biological, and functional properties of the device.
Test methods and parameters
The following parameters may be assessed depending on the nature of the device:
- mechanical integrity
- chemical stability of active components
- sterility maintenance (if applicable)
- label and packaging durability
- performance consistency over time
Shelf life determination
Based on the stability test results, a shelf life is assigned to the device. This includes justification of the chosen shelf life duration and definition of storage conditions (e.g. temperature range, protection from moisture or light).
In some cases, simulated shipping studies are conducted to demonstrate that transport conditions do not adversely affect product stability.
Documentation and regulatory relevance
All stability and shelf life data are compiled into validated test reports and summarized in this section. This information supports the device’s compliance with Annex I of MDR and is necessary for proper labeling, packaging, and risk management documentation.
