MRI Safety Testing

The Importance of MRI Safety

MRI Safety Medical devices, including medical implants, in a magnetic resonance imaging (MRI) environment pose risks, such as electromagnetic interactions and radiofrequency heating, to patients.

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

Medical Device Testing for the MRI Environment

TÜV SÜD is one of the leading providers offering a variety of medical device testing services. Our facility in New Brighton, MN is ISO/IEC 17025:2017 accredited by the American Association for Laboratory Accreditation (A2LA) and can test for various ASTM standards.

Non-active medical implants - MRI Safety

mri safety

MRI Safety Testing and Certification Services

TÜV SÜD offers a wide range of services and tests to assess medical devices' safety in the MRI environment.

Our Services Include:

MRI Safety Product Testing and Labeling:
- Radiofrequency Interactions
  - Induced heating
  - Unintended stimulation
  - Device malfunction
- Gradient Interaction
  - Induced heating
  - Unintended stimulation
  - Induced vibration
  - Device malfunction
- Static Interaction
  - Induced Force
  - Induced Torque
  - Device malfunction
- Image Artifacts
- Labeling
Testing Against the Requirements of the Following Standards
- ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
- ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
- ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Our Highly Skilled Experts Also Offer
- MRI safety testing service for products in the design and development phase
- Testing services throughout the entire product development process
- Training
If you are unable to find the service you require, contact us. Our laboratory offers a wide range of services to meet your needs.

How TÜV SÜD can help you

Key Market Approvals from a Single Partner

We are the world's leading Notified Body in medical device conformity assessment with a high focus on implantable devices. We can issue CB reports and CB certificates accepted in more than 40 countries.

Take Advantage of our “Legacy Device Booster Program”

Solution to label your existing product portfolio for MR Safety and expand life cycle.

Marketing Advantage and a Path to a Competitive MR-Labeling

Our advanced technical knowledge in device testing and regulatory compliance is supported by our global network of healthcare and medical device testing experts, qualified engineers, and medical doctors. Our experts evaluate your medical devices and the MR-labeling to ensure patient safety.

Active Involvement in Standards Development and Implementation

TÜV SÜD actively participates in key standards committees and is involved in standards developments and implementation of medical devices in the EU, U.S., and Asia-Pacific.

FAQs on Medical Device Safety Testing Requirements in an MRI Environment

1. What is MRI safety testing?
MRI safety testing is crucial for all medical devices (such as medical implants) used within a magnetic resonance imaging (MRI) environment. This ensures that these medical devices will not pose risks to the patient. Based on the outcome of these tests, medical device manufacturers are provided MR labeling information that will have information about conditions for which a patient with such devices can undergo an MRI scan.
2. Why are MRI safety and compability testing necessary for medical device manufacturers?
The MRI safety testing of a medical device is necessary to ensure patient safety, implant performance, and compliance with regulations. TÜV SÜD can support you on the subject of testing by offering state-of-the-art laboratories and advantages such as highly skilled professionals, comprehensive international accreditations, and membership in the CB Scheme.
3. What types of devices should be tested for MRI safety?
Currently, the following types of medical devices can 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
4. 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 compatibility assessments and labeling information that should be included in its premarket submissions.
5. What industry standards and regulations reinforce medical device testing for an MR or MRI environment?
Currently, there are FDA-recognized standards that medical devices must be assessed against to ensure total patient safety and device functionality in an MRI environment. These include:
- ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
6. Are there MDR requirements for MRI safety testing?

Yes, 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 assessed for RF-induced heating, image artifact, and magnetically induced displacement force and torque.
7. Where can manufacturers conduct MRI safety testing?

Accredited facilities like TÜV SÜD offer comprehensive MRI safety testing for regulatory compliance and patient safety.
8. 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 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.
9. Are surgical implants, orthopedic, and cardiovascular devices required to undergo MRI safety testing?

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.
10. What types of MRI safety product testing and labeling does TÜV SÜD provide?
TÜV SÜD as an independent testing provider, offers a wide range of services and tests to assess medical devices' safety in the MRI environment, including:
- Radiofrequency interactions such as RF-induced heating
- Static interactions include induced force, induced torque, or device malfunction.
- Image artifacts
- Labeling for MR safe, MR conditional, and MR unsafe device classification.

MRI Safety Testing

The Importance of MRI Safety

Medical Device Testing for the MRI Environment

MRI Safety Testing and Certification Services

FAQs on Medical Device Safety Testing Requirements in an MRI Environment

EXPLORE

Ensuring the Safety of Implantable Medical Devices in a Magnetic Resonance (MR) Environment

MRI Safety Testing for Implantable Medical Devices

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