ASTM F2503

MRI Safety Information and Labeling

ASTM F2503- The labeling of devices as MR Safe, MR Conditional, and MR Unsafe is important for ensuring the well-being of a patient with an implant in the magnetic resonance environment and avoiding serious injury. The patient, the MR technologist and Radiologist should be aware of the implants in a patient and MRI labeling of the implant before scanning occurs. We help evaluate medical devices and provide the required labeling to ensure patient safety which helps provide MRI access to patients with implants.

New EU Medical Device Regulations (MDR)

Are you prepared for the impact of the new EU Medical Device Regulations (MDR), FDA draft guidance and ASTM draft standards for MRI safety evaluations?

Here’s what’s coming:

• MRI labeling will be required for all implants to be compliant as of May 2020.
• All devices that contain any metallic components, such as titanium, (regardless of ferromagnetism) will need to be evaluated and labeled for RF-induced heating, image artifact, force and torque.

Here’s the impact:

• Lengthy new regulation documents and standards will affect all such devices already approved and on the market.
• MRI safety labeling is now considered a component of responsible risk management for your product.

Here’s what you can do now:

• Contact MED Institute. We can provide an audit of any existing MRI labeling and assess your potential needs to comply with the imminent new regulations. If any additional testing is necessary, we can perform that as well.