• MRI safety R&D services - MRI safety testing service for products in the design and development phase
• Testing services throughout the entire product development process
• Training

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The MRI safety testing of a medical device is necessary to ensure patient safety, implant performance, and compliance with regulations. TÜV SÜD's state-of-the-art laboratories, highly skilled professionals, comprehensive international accreditations, and membership in the CB Scheme can facilitate your device's market approval in addition to its medical device certification.

Currently, the following types of medical devices should be tested for MRI safety:

• Fully implanted, passive medical devices
• Active Implantable Medical Devices (AIMDs)
• Partially implanted medical devices
• Medical devices that are external and connected to the body
• Medical devices & equipment used in an MRI scanner environment

The Food & Drug Administration (FDA) provides guidance to the industry with recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment. This guidance includes the recommended format for Magnetic Resonance Imaging (MRI) safety information in medical device labeling.

This guidance document provides recommendations on MRI safety and compatibility assessments and labeling information that should be included in its premarket submissions, including:

• Premarket approval (PMA) applications
• Humanitarian device exemption (HDE) applications
• Premarket notifications such as 510(k) submissions
• Investigational device exemption (IDE) applications
• De Novo requests

The EU Medical Device Regulations (MDR) require medical device manufacturers, especially implant manufacturers, to identify and reduce the risks associated with MRI scanners to ensure patient safety in the MRI environment. Interaction with the Electromagnetic fields of MRI scanners is considered a foreseeable risk, and manufacturers are required to label the devices appropriately. Any device containing metallic, magnetic, or conductive components must be evaluated and tested for RF-induced heating, image artifact, and magnetically induced displacement force and torque.

The MR environment has a variety of unique safety hazards, particularly for patients with implants, external devices, and accessory medical devices. The FDA has implemented a labeling scheme that categorizes whether a medical device or implant is unsafe, conditionally safe, or completely safe to be introduced to an MRI environment.

According to the FDA, here is the current breakdown of MRI Safety Labeling:

• MR Unsafe: The item should not enter an MRI scanner environment, so patients with an MR Unsafe labeled device should not be scanned.
• MR Conditional: The item may safely enter an MRI scanner environment only under the specific conditions outlined in the labeling. Patients should not be scanned unless the device can be positively identified as MR Conditional AND the conditions for safe use are met in this specific scenario.
• MR Safe: The item poses no safety hazards in the MR environment and may be placed anywhere in the MR environment. Patients with MR Safe devices have no scanning restrictions.

Because joint deterioration and corrective orthopedic and surgical procedures are typically monitored via magnetic resonance imaging, many non-active medical implants such as hip joint, knee joint, and shoulder joint replacements must undergo MRI safety testing to assess how these implants will interact and impact an MRI environment. Similarly, cardiovascular medical device implants such as heart valves, stents, catheters, and guidewires should also be thoroughly tested to ensure patient safety.

An AIMD or Active Implantable Medical Device is a device whose operation depends on an electrical energy or power source other than what is generated by the human body or gravity. AIMDs sometimes contain accessories such as lead wires, controllers, and battery packs to operate.

It is intended to be entirely or partially introduced to the human body via surgical or medical means. These devices are implanted to remain post-procedure for extended periods and are subject to more rigorous controls in both the pre-and post-market.

Electrically active devices such as AIMDs can be hazardous within the MRI environment because of the potential interaction with status magnetic fields, RF fields, and gradient fields present, which could cause device failure.