Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
In the EU, there are legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostics (IVDs). These requirements are laid out in 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) respectively.
In practice, these Regulations may need to be applied together in the development of innovative treatments that combine medicinal products with medical devices or IVDs.
Combined studies
In this context, combined studies can be understood as studies that involve:
- A clinical trial of a medicinal product in parallel with a performance study of an in vitro diagnostic
- A clinical trial of a medicinal product in parallel with a clinical investigation of a medical device
The ‘COMBINE’ project
The Member States' competent authorities for clinical trials and medical devices and the European Commission launched this project in June 2023. The COMBINE project aims to analyse the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions to these challenges.
The project involves representatives of competent authorities, the European Commission, medical research ethics committees, the European Medicines Agency, and relevant stakeholders from both the medicinal product and the medical device sectors.
The groups affiliated with this project are the Medical Device Coordination Group and relevant clinical trial groups (Clinical Trials Coordination Group, Clinical Trials Coordination and Advisory Group).
The project consists of two phases: (1) analysis of the challenges at the interface of MDR/IVDR/CTR; (2) possible development of solutions that aim to address some of the challenges.
The analysis phase consists of three strands:
- collecting and analysing the challenges reported by various actors involved;
- mapping relevant national processes and;
- mapping already ongoing work in this area.
Based on this, a fourth strand of work makes proposals for possible solutions to address the most important issues. The analysis was kicked off in September 2023 and is expected to be concluded in April 2024.
See the presentation below for further information on the background of the project, parties involved, the highlights of the four strands and next steps.
Before this project, the Member State competent authorities on clinical trials and IVDs jointly endorsed a guidance document about the status of assays used in clinical trials of medicinal products.
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)
