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.
EC Public Health · December 15, 2025
MDCG Position Paper: Management of SSCP in EUDAMED after mandatory use
Original title: New MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
MDCG guidance on managing single submission/centralised procedures in EUDAMED following mandatory use implementation.
Published by EC Public Health. HealthSignal links to the original document; the summary above is extracted from the source text.