MRI compatibility assessment of implantable medical devices by the CNEDiMTS
|MRI has been constantly increasing over the last few years and numerous technological advances are improving this technique. In order to adapt to these innovations, DMIs must evolve their compatibility characteristics for MRI examination.
In order to clarify its expectations regarding the evaluation of MRI compatibility of DMIs in submitted dossiers, the CNEDiMTS has taken up this issue.
CNEDIMTS recently published new requierements for MRI evaluation. Among the key messages of this evaluation guide:
- The qualification of the MRI compatibility of a medical device is the responsibility of the CE marking. The CNEDiMTS expects to be provided with information on MRI accounting from the CE mark, any existing clinical data and material vigilance.
- The CNEDiMTS insists on the imperative information concerning MRI compatibility of an implant that must be delivered to physicians, patients and electroradiology manipulators in order to facilitate a secure access to MRI.
- All conditions related to MRI compatibility of implants should be found on "My Health Space".
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