CTIMP involving a medical device or in vitro diagnostic medical device

For studies that include a clinical trial of a investigative medicinal product as well as a medical device or in vitro diagnostic medical device, the following additional Appendix must be completed and submitted with the CTIMP application to clinicaltrials@nrec.ie .

Please note, certain combination 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.