Combined studies

What is a combined study?

Combined studies are studies that involve clinical trial of a medicinal product in parallel with clinical investigation of a medical device or a performance study of an IVD medical device. This can be relevant when developing products that combine medicinal products with medical devices or IVD medical devices. Please refer to our websites on Clinical trials of human medicines, Clinical investigation of medical devices and Performance studies of in vitro-diagnostic medical devices (IVDs) for more information.

What requirements apply to combined studies?

When conducting combined studies, the requirements of Regulation (EU) 536/2014 on clinical trials on medicinal products for human use (CTR), Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) must be taken into consideration. 

In Norway, there is currently no combined submission pathway or coordinated assessment of studies that fall under CTR and MDR/IVDR. The process for submitting applications/notifications to NOMA is therefore the same for combined studies as for other studies. However, it should be stated in the cover letter that the study is a combined study. Please refer to our websites on Clinical trials of human medicines, Clinical investigation of medical devices and Performance studies of in vitro-diagnostic medical devices (IVDs) for more information about the process for submitting applications/notifications to NOMA.

The European Commission has published a Q&A-document regarding the interface between CTR and IVDR: MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

EU-project on combined studies (COMBINE)

An EU-project on combined studies (COMBINE) was launched in June 2023 to analyse the interface between CTR, MDR and IVDR. The scope of the project is to analyse the challenges encountered by sponsors when conducting combined studies and to identify possible solutions to these challenges. The project involves representatives from the competent authorities, the European Commission, ethics committees, the European Medicines Agency (EMA) and relevant stakeholders. The first phase of the project has been completed with the publication of a report on the analysis. The next phase of the project will be to develop some of the solutions. Please see the European Commission’s website on combined studies for more information.