Ensuring a smooth implementation and use of the EUDAMED Clinical Investigation and Performance Studies module

Compliance activities for the EUDAMED Clinical Investigation and Performance Studies (CIPS) module are foreseen to be resource-intensive for Sponsors. The ‘minimum viable product’ (MVP) of the central database offers solely manual filling of all CIPS forms for Sponsors. 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 for more automatisation of submission mechanisms to ensure a smooth transition to the implementation and use of the CIPS module.

1. The Sponsor should not be required to submit applications for registering ’ongoing studies’ in EUDAMED once the CIPS module will be mandatory to use as it is seen as duplicative measure and as administrative burden.
2. Prioritise and implement Machine to Machine (M2M) and XML functionalities for upload and download of the Serious Adverse Events (SAE) form before the notice confirming the functionality of the CIPS module is published in the Official Journal of the EU.
3. Provide a transition period for mandatory use of CIPS module. The CIPS module should be launched in production and be made accessible for users as soon as the notice confirming the functionality of the CIPS module will be published in the OJEU, and not 6 months later when its use is mandatory. Provide transition guidance.

This CIPS specific position paper is connected to the broader EUDAMED position paper released in December 2024: Smooth transition to the mandatory use of EUDAMED – Perspectives from manufacturers.

Read the full position paper below.