MDCG Position Paper: UDI assignment between manufacturers and distributors

This page provides a range of documents to assist stakeholders in applying: Regulation (EU) 2017/745 on medical devices (MDR)andRegulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number-revision”. The documents on this page are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.