MR safety testing for medical devices

Magnetic resonance imaging is a routine part of modern healthcare, and its continued growth places clear expectations on medical device manufacturers. Devices that may be exposed to the MR environment must be shown to operate safely without putting patients, clinicians, or diagnostic results at risk.

Without a structured testing strategy, these risks can lead to significant economic impact:

• delays in regulatory submissions and market access
• lower market share due to time to market delays
• lower market acceptance and competitor pressure
• costly redesigns in a late design and development phase
• unexpected safety relevant impact resulting in liability claims

Regulators in both the United States and the European Union now expect clear, evidence-based demonstration of MR safety. FDA guidance and EU MDR requirements emphasize risk-based evaluation, validated test methods, and accurate labeling (MR Safe, MR Conditional, MR Unsafe).

 

What you’ll learn in this white paper

• Key MRI-related hazards and how they impact device performance
• The most relevant standards for MR safety testing (ASTM methods and labeling requirements)
• How to structure a testing strategy aligned with regulatory expectations
• Common pitfalls that lead to delays or rework and ultimately jeopardize the go-to-market strategy
• Practical considerations to support reliable and smoother submissions

 

Why this matters

Well-planned MR safety testing supports compliance and helps you:

• de-risk submissions and speed up market access
• keep timelines on track and defend revenue potential
• increase confidence in your MR claims and reduce competitive pressure
• prevent expensive late design changes
• reduce safety-related surprises and liability risk

 

Download the white paper

Gain practical insight into how to approach MR safety testing with confidence and support successful market access.