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 of 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 to develop innovative treatments combining 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
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 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 medicinal product and medical device sector stakeholders.
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:
- analysis of the challenges at the interface of MDR/IVDR/CTR.
- 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 of already ongoing work in this area.
Project Deliverables
The project completed its first phase with the publication of the analysis report in May 2024 which includes proposals for possible solutions to address the most important issues. The next steps of this project will involve developing some of the solutions.
Next steps
The second phase of COMBINE will involve a set of projects to address the issues identified in the analysis phase. It is more complex than the first phase. The sectors will need to collaborate more in-depth and consider already ongoing activities. The various actors involved in COMBINE are shaping the organisation of the second phase to address the identified issues in the most efficient way. The planning for the second phase of COMBINE is expected to be finalised in the second half of 2024.
Background
The presentation below includes further information on the projects's background, parties involved, the highlights of the four strands and the 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)
