Nervous and medullary systems devices in EUDAMED
Browse medical devices in the “Nervous and medullary systems devices” EMDN category registered in EUDAMED. Each result links to its manufacturer, certificates, and identifiers.
1001 medical devices in EUDAMED
About the Nervous and medullary systems devices category
Nervous and medullary systems devices act on the brain, spinal cord and peripheral nerves — neurosurgical instruments, shunts and drainage systems for cerebrospinal fluid, and devices placed in or near the central nervous system. Contact with the CNS is one of the MDR’s sharpest risk triggers: under Rules 7 and 8 such devices are pushed toward Class III, so this is a heavily certified branch. Procedure volumes are lower than commodity categories, but the clinical and regulatory bar is among the highest.
Common questions
Which neurological devices are in EMDN category N?
It includes neurosurgical instruments, CSF shunts and external ventricular drains, and other devices intended to act on or contact the central or peripheral nervous system.
Why does central-nervous-system contact raise the risk class?
The MDR singles out contact with the central nervous system: under Annex VIII Rules 7 and 8 a device in such contact is classified Class III, the highest tier, because the consequences of failure are severe and often irreversible.