CTIMP involving a medical device or in vitro diagnostic medical device

Certain combined studies are a subject to both NREC-CT and NREC-MD review, for example studies carried out under both CTD/ CTR and MDR or IVDR, particularly if the study is subject to review by both CT and MD team of the HPRA.

In such cases, a separate full application to NREC-MD is necessary. For more information on the NREC-MD application process, please visit the NREC-MD website.