MRI Safety Testing

Elevate your medical device testing to global standards

Elevate your medical device testing to global standards

THE IMPORTANCE OF MRI SAFETY TESTING

Presence of medical devices, including medical implants, in or near a magnetic resonance imaging (MRI) scanner environment pose risks due to the electromagnetic interactions such as 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 facilities in Minnesota can test the following example devices for MRI Safety: (This is not a complete list, for more details please contact [email protected])

Medical device testing for MRI environment

Request for a Medical Device Testing in an MRI environment today

 

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:

 

WHY CHOOSE TÜV SÜD

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.

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.

Request for a Medical Device Testing in an MRI environment today

FAQs on Medical Device Safety Testing Requirements in an MRI Environment 

  • 1. Why are MRI safety and compatibility 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'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.

  • 2. 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
  • 3. 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, 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
  • 4. 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.

  • 5. 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.
  • 6. 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.

  • 7. 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 status magnetic fields, RF fields, and gradient fields present, which could cause device failure. 

EXPLORE

MRI safety testing webinar
Webinar

MRI Safety Testing Overview

View the on-webinar to learn about the risks associated with the medical devices in the MRI environment.

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