SAM
Designating authority · Estonia · Tartu
A national authority responsible for designating and monitoring notified bodies under the EU MDR/IVDR.
EUDAMED publishes limited fields for authorities — some details may be unavailable.
Capability matrix published by EUDAMED for this authority.
EUDAMED does not publish a machine-readable link between a designating authority and the notified bodies it has designated. That relationship currently lives only in the EU's NANDO database.
A designating authority designates and monitors notified bodies under MDR Article 35 / IVDR Article 31 — the bodies that certify devices. It does not itself certify devices or validate economic operators.
Explore every authority and economic operator registered in Estonia.
All authorities & operators in EstoniaA national body that designates and monitors the notified bodies in its country — the conformity-assessment bodies authorised to certify medical devices.
No — that's a notified body. A designating authority appoints and supervises notified bodies; it does not issue device certificates itself.
Sourced directly from EUDAMED. This record was last updated Jun 25, 2026.