MDCG 2021-15 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) – July 2021 MDCG 2021-16 : Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) – July 2021

3 Sep 2021 | All the News, MDCG

Theme Designation as notified body
Target Audience Conformity assessment bodies
Products concerned MD & IVD
Documents mentioned

MDR (EU) 2017/745

IVDR (EU) 2017/746

These MDCG guides (15 & 16) correspond to the forms to be completed by conformity assessment bodies when applying for designation as notified body under Regulation (EU) 2017/745 for medical devices and Regulation (EU) 2017/746 for in vitro diagnostic medical devices.