Application that involves testing of drugs and medical devices (combination trials)
If a study involves testing of medicinal products that falls within the scope of Clinical Trials Regulation (CTR) in combination with a study regulated by MDR or IVDR, two separate applications must be submitted.
The pharmaceutical clinical trial must be applied for under CTR with an application to CTIS which is assessed by NoMA and REK KULMU. The application for the performance study (IVDR) must be submitted to REK via the REK portal, and if necessary to NoMA if the study is subject to notification or application to NoMA, see NoMAs websites for further information.
It must be clearly stated in the ICF(s) what participating in the clinical investigation/performance study entails. The sponsor may create one common ICF for both studies (the CTR trial and the IVDR study) or create two separate ICFs. Please see the REKs ICF templates for more details.
