Stability Studies of Medical Devices

Accelerated aging studies provide alternate means in a case where the product becomes obsolete in a short time due to market conditions and there is a need to get a new product to the market in the shortest possible time.

• Select the Q10 value and define the expected shelf life of the package, such as, marketing needs, product needs, etc.
• Define aging test time intervals, including time zero.
• Expected test conditions, room temperature (TRT), and accelerated aging temperature (TAA).
• Evaluate the test duration using the Q10, TRT, and TAA.
• Explain the package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria
• Age samples at TAA. In parallel, age samples at real-time aging conditions (TRT).
• Assess the package performance after accelerated aging relative to the initial package requirements, for example, package seal strength, package integrity.
• Assess the package, or package performance, or both, after real-time aging relative to the initial package requirements.
• The estimated AAF method is a simple and conservative technique for evaluating the long-term performance of a package; however, like all accelerated aging techniques, it must be confirmed by real-time aging data

The stability study of medical devices is a scientific assessment that determines how well a medical device maintains its quality, safety, and performance over time when exposed to various environmental conditions like temperature, humidity, light, and transportation stress. It helps establish the device’s shelf life or lifespan. Stability can be evaluated through accelerated (short-term, high-stress) or real-time (long-term, normal conditions) testing. These studies consider factors such as packaging, storage, materials used, and manufacturing methods. The results ensure that the device remains effective and safe throughout its intended use period.

Stability studies are crucial for CE marking because they demonstrate that a medical device maintains its safety, quality, and performance throughout its intended shelf life under defined storage and usage conditions. Regulatory bodies require this data to ensure that the device will function as intended over time without posing risks to patients or users. Stability studies—both accelerated and real-time—help verify the device’s resistance to environmental factors such as temperature, humidity, and handling stress, which is essential for meeting EU MDR requirements and gaining market approval.

Stability testing for medical devices includes two key types:

1. Accelerated Stability Testing: storing the device under elevated stress conditions (such as higher temperature, humidity, or pH) for a shorter period to predict its shelf life and identify potential degradation pathways.

2. Real-Time Stability Testing: storing the device under recommended storage conditions and testing it at specific intervals to confirm its actual shelf life and performance consistency.

Both types are essential to evaluate how environmental factors affect the quality, safety, and effectiveness of a device over time. Additional considerations may include packaging integrity, transportation stress, and microbiological, chemical, physical, therapeutic, and toxicological stability.

Shelf life for medical devices is determined through stability studies that evaluate how long a device maintains safety, quality, and performance under expected conditions. Two main methods are used: accelerated testing simulates long-term aging by exposing the device to elevated stress (e.g., temperature, humidity), while real-time testing monitors the device over time under normal conditions. Key considerations include material composition, packaging, storage, transport stress, and intended use. Chemical, physical, microbiological, and toxicological properties are assessed. Initial shelf life claims may be based on accelerated data but must be verified with ongoing real-time studies to ensure long-term reliability and compliance.

Maven can assist with medical device stability studies by designing a comprehensive and compliant stability study plan tailored to your device type and intended use. Our experts help identify applicable international standards, determine appropriate testing methods (accelerated and real-time), and define critical parameters such as storage conditions, sampling plans, packaging evaluations, and transport simulations. We also support ongoing stability monitoring post-market to ensure consistent device performance throughout its shelf life. With Maven, you can minimize errors and ensure reliable stability data to meet regulatory expectations.