CNEDiMTS assessment of the MRI compatibility of implantable medical devices
Health technology assessment - Posted on Nov 18 2021
Between 2008 and 2018, the number of MRI units in public and private non-profit institutions practically doubled. In 2018, the number of procedures was estimated at 600,000 for hospitalised patients and 2.1 million for outpatients. Despite a growing number of MRI examination requests, this imaging technique exposes patients with certain types of implants to functional and even vital risks.
Key points :
- Given the growing number of MRI examinations conducted, implants that have become MRI compatible under defined conditions constitute a normal technical evolution.
- MRI compatibility is subject to CE marking. The CNEDiMTS examines the MRI compatibility information stemming from the CE marking process, as well as any existing clinical data and medical device vigilance data.
- The CNEDiMTS insists on the imperative necessity to provide information on the MRI compatibility of an implantable medical device to physicians performing the implantation, patients, doctors requesting an MRI examination and radiographers in order to ensure safe MRI access.
- All of the conditions concerning the MRI compatibility of implants should be available on the health platform “Mon espace santé”.
Contact évaluation des dispositifs