Theme Designation as notified bodies
Target Audience Conformity assessment bodies
Products concerned


Documents mentioned

MDR (EU) 2017/745

IVDR (EU) 2017/746

Commission implementing regulation (EU) 2017/2185


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.