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 in vitro diagnostic (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 IVD medical devices 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. We still recommend that you submit the application under CTR and MDR/IVDR at the same time, so that we can ensure that the applications are handled in the best way possible at NOMA. Please also state 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 IVD medical devices 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 COMBINE project seeks to make the EU an attractive region to conduct combined studies. The project involves representatives from the competent authorities, the European Commission, ethics committees, the European Medicines Agency (EMA) and relevant stakeholders. The project consists of two phases:

1. Analysis of the challenges at the interface between MDR, IVDR and CTR.
2. The possible development of solutions that aim to address some of the challenges.

In May 2024 the first phase of the project was completed with the publication of a report on the analysis. The strategy for the next phase was endorsed by the Member States in December 2024. This phase consists of several projects that will develop some of the solutions presented in the analysis report. This will involve looking at opportunities for coordinated assessment of combined studies, alignment between Member States on different concepts and requirements, and possibilities related to communication and dialog. Please see the European Commission’s website on combined studies for more information.