Notified body

Notified bodies are independent organizations designated by a Member State and assessed by joint assessment teams. Most devices above class I under the MDR, and most IVDs under the IVDR, need one, and the manufacturer can choose any notified body designated for its type of device.

‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

EU MDR, Article 2(42)

‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

IVDR, Article 2(34)