Ensuring an efficient implementation and use of the EUDAMED Clinical Investigation and Performance Studies module

Posted on 03.04.2025

As part of MedTech Europe’s advocacy on EUDAMED, a Clinical Investigation and Performance Studies module (CIPS)  specific position paper has been published.

Compliance activities for the EUDAMED CIPS module are foreseen to be resource-intensive for Sponsors. The central database offers solely manual filling of all CIPS forms. Also, the CIPS coordinated assessment procedure by Competent Authorities will not be mandatory until 2033, necessitating CIPS application and notification forms to be submitted separately for each country where the same investigation or study is being run, even once the CIPS module as part of the central European database becomes mandatory to use (currently planned for 2027-28).

Therefore, Sponsors ask to eliminate duplication in administrative processes and automate submission mechanisms more to ensure a smooth transition to the implementation and use of the CIPS module.

For more information, please contact Katalin Máté, Senior Expert Regulatory Affairs (IVDR & MDR)