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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: Below is not a complete list, for more details please contact us.
What our MRI safety testing service includes
We offer a comprehensive portfolio of services and testing solutions to evaluate the safety of medical devices in the MRI environment. Our approach is tailored to the specific characteristics of each device and aligned with the latest state-of-the-art requirements. Rather than applying a one-size-fits-all model, we rely on the deep expertise of our seasoned professionals — each with hands-on experience across a wide range of devices and MRI scenarios.
Our goal is to make the complex simple: we strive to deliver solutions that not only meet technical and clinical expectations but also minimize the effort required for regulatory submissions worldwide. With us, you gain a trusted partner committed to accelerating your path to market with confidence and compliance
Our services include:
Our accreditation:
Our highly skilled experts also offer
- Solution-Oriented Project Planning - We go beyond the one-size-fits-all approach—our project planning is driven by your device’s unique needs and development goals.
- MRI safety R&D services - From early design to final development, we offer comprehensive MRI safety testing services that support every phase of your product lifecycle.
- Feasibility testing - Accelerate innovation with our streamlined feasibility studies
- Legacy Device Testing - Extend the value of your existing portfolio. Our legacy testing services help safeguard market share and ensure continued compliance.
- Optimized Timelines - We understand time-to-market matters. That’s why we align our testing services with your development schedule, efficient, reliable, and on time.
- Regulatory Readiness Built-In - Our solutions are designed to minimize the effort required for global regulatory submissions, helping you navigate compliance with confidence and clarity.
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 conditional 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
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 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 conditional 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 any EU 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 devices within the MRI environment including implanted and non-implanted, pose device specific hazards like device malfunction, induced heating, and mechanical interactions. Our testing experts will provide state-of-the-art project planning for your device.
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?
Active Implantable Medical Devices (AIMDs) are electrically powered devices, such as pacemakers or neurostimulators, that rely on an external energy source rather than the body’s own physiological mechanisms. These devices often include components like lead wires, controllers, and battery packs to support their function.
Designed to be partially or fully implanted in the human body through surgical or medical procedures, AIMDs are intended for long-term use and are therefore subject to stringent regulatory scrutiny both before and after market approval.
However, within the MRI environment, AIMDs face significant safety challenges. The interaction with powerful static magnetic fields, radiofrequency (RF) fields, and gradient fields can lead to:
- Mechanical forces that may cause device displacement or torque,
- Excessive heating of device components, particularly leads and electrodes,
- Malfunction or unintended stimulation due to electromagnetic interference, and
- Permanent device damage, potentially compromising patient safety and therapy effectiveness.
These risks underscore the critical importance of thorough MRI safety evaluation for AIMDs to ensure both device integrity and patient well-being.
What are the MRI Safety Considerations for Non-Implantable Devices?
Non-implantable medical devices — whether active (electrically powered) or passive — can pose significant safety risks in the MRI environment. These risks are highly device-specific and depend not only on the device’s design and materials but also on its intended location during MRI exposure.
Key hazards include:
- Mechanical Forces: Ferromagnetic components may experience strong attraction or torque, especially if positioned within or near the MRI bore.
- RF-Induced Heating: Conductive materials, such as cables or electrodes, can absorb radiofrequency energy, leading to localized heating that may damage the device or surrounding tissue.
- Electromagnetic Interference: Active devices may malfunction or behave unpredictably due to interactions with static, gradient, or RF fields.
- Device Damage or Degradation: Sensitive electronics or materials may suffer irreversible damage, compromising performance or safety.
Location matters:
- Devices Inside the MRI Bore are exposed to the highest field strengths and energy levels, requiring rigorous evaluation for displacement, heating, and functional integrity.
- Devices Positioned Outside the Bore may still be affected by fringe fields or cable coupling effects, but the risk profile differs significantly and must be assessed accordingly.
MRI safety evaluations need to be tailored to reflect these nuances—ensuring that each device is assessed based on its specific use case, configuration, and exposure scenario. This approach helps mitigate risk, protect patients and staff, and support smoother regulatory submissions.