Submission of a clinical investigation of medical devices to CEIC

 

Applications for conducting and notifications of clinical investigations of medical devices must be submitted under Regulation (EU) 2017/745, via RNEC, to INFARMED, I.P. (Member State contact point). INFARMED, I.P. and the CEIC will coordinate for the purposes of validation and evaluation of the studies.

The submission rules are described in the tab - Submission of a clinical investigation of devices in Portugal -