| QAdvis AB

According to MDR 2017/745 “Devices shall be designed and manufactured in such a way as to ensure that their characteristics and performance during their intended use are not adversely affected during transport and storage…” This implies the need for transport validation, meaning that you must demonstrate that the device quality is not compromised during shipping or storage — especially for temperature-sensitive, fragile, or sterile devices. You need to ensure that products maintain their safety, integrity and performance from the moment they leave the manufacturer until they reach the end user.

Transport validation is the process to demonstrate that your medical devices can withstand the conditions they will be exposed to during transportation, such as varying temperature, humidity, shock, and vibration—without being compromised. The process typically involves simulating real-world shipping conditions (e.g., drop tests, vibration tests, temperature cycling) and monitoring the actual shipments with data loggers.

Activities for how to perform transport validation:

Define product scope
Identify shipping method, routes, environmental conditions, consider worst-case-scenario
Perform a risk assessment to identify potential hazards and sensitivities
Develop a test plan, including criteria for approval
Conduct simulated testing and/or real-world shipment validation
Evaluation of the result
Summarize the validation report,
Re-validate any identified nonconformities

Ensuring adequacy in packaging for all logistical scenarios is important to ensure patient safety as damaged or degraded devices can pose serious risks during use of the medical device, and also to ensure regulatory compliance and reduce the risk of product loss, recalls, or reputational damage.

Key takeaways:

Integrate transport validation into your design and development process early.
Tailor the validation to product type, fragility, and risk class.
Periodically revalidate if shipping methods, packaging, or routes change.
Document everything in line with your QMS and regulatory requirements.
Transport validation isn’t just about ticking boxes—it’s about ensuring that devices arrive safely, ready to do their job where it matters most.