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What is MRI safety testing?
The presence of medical devices, including medical implants, in or near a magnetic resonance imaging (MRI) scanner environment poses risks to patients due to electromagnetic interactions such as radiofrequency heating. This is why experts from a trusted body such as TÜV SÜD should perform MRI safety testing of medical devices. This is necessary to ensure patient safety, medical device performance, and compliance with the regulations.
How TÜV SÜD can help you with MRI safety testing
TÜV SÜD is one of the world’s largest Notified Bodies for medical devices. We have specialised expertise in implantable devices. Our state-of-the-art laboratories support our testing experts, engineers and medical doctors to test and certify medical devices.
We are a member of the IEEE-CE Scheme, an international system for mutual recognition of test results for electrical and electronic components. We actively participate in key standards committees, and are involved in standards development and implementation in the EU, U.S. and Asia-Pacific.
We offer a wide variety of medical device testing services. Our facilities in Minnesota can test the following example devices for MRI safety. Note: Below is not a complete list, for more details please contact us.
What our MRI safety testing service includes
We offer a wide range of services and tests to assess medical devices' safety in the MRI environment. Our services include:
- MRI safety testing and product MR labeling
- Testing against the requirements of the following standards
Our highly skilled experts also offer
- MRI safety R&D services - MRI safety testing service for products in the design and development phase
- Feasibility testing
- Testing services throughout the entire product development process
- MRI safety testing of legacy devices in the market
- Training
If you are unable to find the service you require, please contact us. Our laboratory offers a wide range of services to meet your needs.
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Frequently Asked Questions (FAQs)
Why are MRI safety and MRI compatibility testing necessary for medical device manufacturers?
The MRI safety testing of medical devices, particularly implantable devices, is necessary to ensure patient safety, product 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 may facilitate your device's market approval in addition to its medical device certification.
What types of devices should be tested for MRI safety?
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
- 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
What is the FDA guidance on MRI safety testing?
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 MRI 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
This guidance document provides recommendations on MRI safety and MRI 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
Are there MDR requirements for MRI safety testing?
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. Additional tests are applicable to active implantable devices.
How does MRI safety labeling work, such as MR Safe, MR Conditional and MR Unsafe?
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 categorises 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 condition 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.
Are surgical implants, orthopedic and cardiovascular devices required to undergo MRI safety testing?
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 with MRI environment. Similarly, cardiovascular medical device implants such as heart valves, stents, catheters, and guidewires should also be thoroughly tested to ensure patient safety.
What is an AIMD, and does this type of medical device implant require MRI safety testing?
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 static magnetic fields, RF fields, and gradient fields present, which could cause device failure and harm the patient.
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 static magnetic fields, RF fields, and gradient fields present, which could cause device failure and harm the patient.
