Studies which include an investigational medicinal product (carried out under the Clinical Trials Regulation) and a medical device and/or an in vitro diagnostic medical device (carried out under the Medical Device Regulation /In Vitro Diagnostic Medical Device Regulation) require review and approval by both NREC-MD and NREC-CT.

Two separate applications are required for NREC-MD and NREC-CT. These applications can be submitted separately or in parallel.

Apply to NREC-MD

Apply to NREC-CT

The application documentation should be completed with the remit of each Committee in mind, eg an application to NREC-MD should focus on and outline the clinical investigation / performance study.

Following validation, each committee will conduct their own independent review within their independent remits. The NREC-MD will only review and approve aspects and documents of the study pertaining directly to the clinical investigation/ performance study in question. Aspects of the clinical trial for investigative medicinal products (CTIMP) which require ethical review will not be reviewed or approved by NREC-MD.