Conformity assessment body

A conformity assessment body becomes a notified body only once it is designated under the MDR or IVDR. Test labs that are conformity assessment bodies can still provide test reports for a technical file.

‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

EU MDR, Article 2(41)

‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

IVDR, Article 2(33)