What is a “Notified Body”, why do they exist and what do they do?

A Notified Body (NB) is an independent organisation officially approved by an EU Member State to act as a safety gatekeeper. Before a manufacturer can sell a medical device in the EU, a Notified Body must review the technical evidence and issue a certificate confirming the device meets legal regulatory requirements (EU MDR / EU IVDR) — similar to a safety inspector signing off an airplane before people can fly in it. NBs come in all shapes and sizes, some are SMEs, some are linked to the government of their Member State, some are semi-state and some are fully private businesses. Team-NB is the association that represents over 85% of all NBs.