Basic Concepts – certificates types
In EUDAMED, and in line with the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, certificates are classified into two main types: Product and Quality, with each having its own types of certificate.
Product certificates:
EU Type Examination certificate (Annex X);
EU Technical Documentation certificate (Annex IX Chapter II);
EU Product Verification certificate (Annex XI Part B).
Quality certificates:
EU Quality Management System certificate (Annex IX Chapter I);
EU Quality Assurance certificate (Annex XI Part A);
EU Production Quality Assurance certificate (Annex XI).