MRI safety labeling

Change is on the horizon for labeling of medical devices

If you missed us at RAPS Convergence 2021, you can reach out to our team and we would be happy to share our slides. 

Our team shared information about how MRI safety labeling is changing.  It is important for individuals involved in regulatory affairs to be aware of changes to MRI safety labeling requirements for medical devices. It is also important to be aware of the fundamental MRI safety concerns (i.e., force, torque, image artifact, and RF heating), the corresponding standard test methods, and how the results from the testing form the MRI safety label that is reported in the instructions for use (IFU) for medical devices. In addition, it is critical to understand how the labeling requirements have changed and how to implement these changes in upcoming regulatory submissions. For more information, see FDA’s current guidance Testing and Labeling Medical Devices for Safety in the MR Environment (May 2021).

Several safety concerns exist when patients with metallic implants require diagnostic MRI. These concerns include magnetic forces, torques, radiofrequency-induced heating, gradient-induced heating and vibrations, unintended stimulation, and device malfunction. One of our core proficiencies is helping medical device manufacturers evaluate their devices for safety in the MRI environment. We evaluate your device by testing to many International Standards for MRI Safety, such as:

  • ASTM F2213 –Magnetic torque
  • ASTM F2119 –Image artifact
  • ASTM F2052 –Magnetic force
  • ASTM F2182 –RF-induced heating
  • ASTM F2503 –MRI safety labeling
  • ISO/TS 10974 –Electrically active devices (AIMD)

For more information about our services and how we can help accelerate your product development, please contact us.
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