MDCG 2021-17 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) – July 2021 MDCG 2021-18 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) – July 2021

These MDCG guides (17 and 18) are the forms to be completed by conformity assessment bodies to define the types of products for which they consider themselves competent and request designation under Regulation (EU) 2017/745 for medical devices and Regulation (EU) 2017/746 for in vitro diagnostic medical devices.