|Theme||Designation as notified bodies|
|Target Audience||Conformity assessment bodies|
MD & IVD
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.