Reusable surgical instruments in EUDAMED
Browse medical devices in the “Reusable surgical instruments” EMDN category registered in EUDAMED. Each result links to its manufacturer, certificates, and identifiers.
1001 medical devices in EUDAMED
About the Reusable surgical instruments category
Reusable surgical instruments are the hand-held, non-powered tools designed to be used, cleaned and re-sterilised many times — scalpels and blades holders, forceps, retractors, scissors, clamps and similar instruments. They carry a notable regulatory quirk: under MDR Rule 6 reusable surgical instruments benefit from a Class I exception even though they are surgically invasive, though sterility and reprocessing obligations still apply. The category is broad, fragmented across many manufacturers, and central to every operating theatre.
Common questions
What is a reusable surgical instrument in EMDN terms?
It is a hand-operated instrument, with no connection to an active device, intended to be reprocessed and reused — for example scalpel handles, forceps, retractors, clamps, scissors and probes used during surgery.
Why are reusable surgical instruments often Class I despite being invasive?
MDR Rule 6 grants reusable surgical instruments a specific Class I carve-out, but they remain subject to obligations around reprocessing validation and, where supplied sterile or with a measuring function, the relevant Notified-Body involvement for those aspects.