Medical devices are products t hat have a medical purpose for use in humans. They include a wide range of products, such as surgical instruments, implants, diagnostic products, dressing materials and devices for rehabilitation or for monitoring vital functions. Medical devices can also be products that contain or are coated with a substance that can be considered a medicinal product when used separately. Trade in medical devices is governed by EU regulations that regulate the placing on the market and putting into service of such products.
The EU Medical Device Regulation (MDR) also has an impact on the logistics of medical devices. According to the MDR, manufacturers of medical devices must demonstrate the conformity of their products and ensure that they are safe and effective. They must also ensure that their products are not damaged or contaminated during transportation, storage and handling, which could compromise their safety or effectiveness.
Logistics service providers must adhere to certain obligations, particularly when storing and transporting medical devices. These include complying with specific storage conditions, monitoring temperatures and humidity and checking packaging. They must also have suitable quality management systems in place and ensure complete traceability of medical devices. The MDR (Medical Device Regulation) increases the responsibility of logistics service providers and requires careful compliance with standards.
