Magnetic resonance imaging (MRI) technology plays an important role in healthcare in the diagnosis, treatment, and management of various types of cancers and a range of other medical conditions.
However, MRI technologies presents potential hazards to patients with implantable medical devices, as well as to personnel in the MRI scanner environment. These hazards can compromise the operation of these potentially life-saving devices and place the health and safety of patients at risk. Accordingly, implantable medical devices must be thoroughly evaluated and tested to ascertain the possible impact of such hazards and degree of potential risk in the MR environment.
In this white paper, we’ll discuss the potential hazards associated with the use of MRIs and the steps that medical implant manufacturers must take to ensure the safe operation of their devices in an MR environment. We’ll also provide an overview of the current regulations in the European Union (EU) and the United States (U.S.) that are applicable to medical implants, and the specific testing that can help ensure the safe operation of implants and the safety of patients. Finally, we’ll share some guidelines on steps that device manufacturers can take to thoroughly evaluate their products for compliance with applicable standards and successfully navigate the anticipated regulatory challenges.
This whitepaper covers: