Glossary

Conformity assessment body [MDR/IVDR]

MDR IVDR

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

 

[Definition under (EU) 2017/745 Article 2 No. 41 also corresponds to definition under (EU) 2017/746 Article 2 No. 33]