Transport testing, as part of the EU 2017/745 Medical Device Regulation (MDR), is crucial to ensure that medical devices maintain their safety, integrity, and functionality during transportation. Medical devices, which can vary from complex diagnostic devices to small surgical equipment, are often exposed to various stresses during shipping and handling. Therefore, it is essential to meet stringent testing requirements to ensure these products arrive in perfect condition and are ready for safe use.

This article explores the importance of transport testing in medical device development, its role in MDR compliance, the methods used, and best practices for ensuring a safe and reliable transport process.

MDR Transport Testing Requirement

Transport testing is one of the requirements of Medical Device Regulation (MDR), which sets out comprehensive requirements for the safety, performance, and risk management of medical devices throughout their lifecycle. The regulation aims to ensure that medical devices are transported in a way that maintains their quality, reduces risks of damage, and protects patient safety.

MDR GSPR 11.4. Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.

Let’s take a look at the details of the transport testing.

What is Transport Testing in Medical Devices?

Transport testing involves simulating the conditions that medical devices may encounter during storage, handling, and transportation. The goal is to ensure that the device and its packaging can withstand various stresses, such as vibration, shock, compression, impact, temperature fluctuations and humidity changes.

The tests help determine whether the packaging and device can maintain their structural integrity and functionality after being subjected to real-world conditions during distribution. Of course, a set of standards or guidelines is needed to perform these tests.

What are key standards and guidelines for transport testing?

Transport testing for medical devices is guided by international standards and guidelines that align with the MDR. Some of the key standards include:

• ISO 11607-1 and ISO 11607-2: These standards focus on the packaging for terminally sterilized medical devices and guide packaging system requirements and validation testing.
• ASTM D4169: This is a standard for performance testing of shipping containers and systems, offering a framework for simulating the environmental hazards of transportation.
• ISTA (International Safe Transit Association) Standards: ISTA provides test procedures that simulate real-world transport conditions, ensuring that medical devices are tested under appropriate environmental scenarios.
• EN 868: This standard complements ISO 11607 and provides additional details on materials and systems used for medical device packaging.

After reviewing the standards, let’s take a look at the most common tests used in transport testing.

Common Transport Testing Methods

Several methods are used to assess medical device packaging and transportation safety.

1. Vibration Testing: Simulates the continuous movement that products endure during transportation, ensuring devices and packaging can withstand vibrational forces encountered during air, sea, and land shipping.
2. Shock Testing: Evaluates the device’s ability to withstand sudden impacts, such as drops during handling or transportation. This ensures that devices remain intact even when subject to accidental shocks.
3. Compression Testing: Assesses the ability of the packaging and the device itself to resist forces that may occur during stacking or when subjected to heavy loads in transit.
4. Climatic Testing: Evaluates the impact of extreme temperatures and humidity levels on medical devices, simulating environments such as cargo holds in aeroplanes, where temperatures can fluctuate drastically.
5. Drop Testing: Simulates the effect of dropping during handling and transport to assess whether the packaging and device can withstand falls from specified heights without being damaged.

In order to conduct an effective and successful transportation test, the following factors must be considered.

1. Develop a Risk-Based Testing Approach: Prioritize testing based on the type of device, its materials, and the conditions it will encounter during transportation. High-risk devices may require more comprehensive testing.
2. Early Integration of Transport Testing: Incorporate transport testing early in the product development process. This ensures that potential weaknesses in packaging or materials can be addressed before devices are mass-produced and distributed.
3. Collaborate with Logistics Partners: Work closely with shipping and distribution partners to understand the real-world conditions your devices will face. This collaboration can help tailor testing protocols to reflect actual transport scenarios.
4. Maintain Detailed Documentation: For MDR compliance, manufacturers must maintain extensive documentation of transport testing results, including the methodologies used, the results, and any corrective actions taken.
5. Continuous Monitoring and Improvement: Conduct regular reviews of transport testing protocols, especially when introducing new devices or materials or when changing logistics providers.

Transport testing is critical to the medical device lifecycle, ensuring that devices arrive at their destination intact and safe for use. Under the MDR, compliance with transport testing requirements safeguards patient safety and helps manufacturers maintain product integrity and reduce costs associated with device damage. By adhering to international standards and employing best practices, medical device manufacturers can ensure that their products are suitable for use, even after enduring transportation challenges.

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