Last updated: 13 September 2026
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What are combined studies?
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.
What is COMBINE initiative?
COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research.
The Member States’ competent authorities for clinical trials and medical devices and the European Commission launched the COMBINE initiative in June 2023, with the aim of:
- analysing the root causes of the challenges encountered by sponsors in conducting combined studies
- identifying possible solutions.
What are the two phases of the COMBINE initiative?
The initiative includes two phases:
- analysis of the challenges at the interface of MDR/IVDR/CTR (including collecting and analysing the challenges reported by various actors involved, mapping relevant national processes and already ongoing work)
- possible development of solutions that aim to address some of the challenges.
The launch of the COMBINE pilot project
- As part of the COMBINE programme, the European Commission and EU Member States launched a pilot project in June 2025 to test a new, more efficient way of approving combined studies.
- These studies involve both clinical trials of medicines and performance studies for medical devices.
Timeline of the COMBINE project
| Month/Year | Deliverable |
|---|---|
| May 2024 | COMBINE 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. |
| December 2024 | In December 2024, the Member States endorsed the strategy for the second phase, which is organised as a programme consisting of several projects. This programme will develop some of the solutions presented in the analysis report. |
| June 2025 Combine Project 1 pilot – Phase 1 | On 13 June 2025, a pilot coordinated assessment process for multinational combined studies was launched as part of Project 1 of the COMBINE programme. Phase 1 of the pilot is exploring the feasibility of a coordinated assessment procedure. The pilot is expected to streamline the authorisation process, reduce administrative burden for sponsors and accelerate patient access to innovative treatments. |
| June 2026 COMBINE project 1 pilot – Phase 2 | The project proposes a phased pilot approach to test the feasibility of such a coordinated process. The pilot is designed to allow sponsors of combined studies to submit a single application for coordinated assessment. The European Commission, participating Member States and the European Medicines Agency (EMA) announced the launch of the second phase of the pilot on 26 June 2026. This phase expands the scope of accepted applications and will extend the expression of interest period (this pilot phase will remain open for at least one year). For this pilot phase, combined study applications should involve: a medicinal product clinical trial combined with an i) in vitro diagnostic medical device simultaneous performance study conducted by either the same eligible sponsor or separate sponsors, or ii) a medical device clinical investigation conducted by either the same eligible sponsor or separate sponsors. |
| 11 September 2026 Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies | COMBINE Project 2 is part of the COMBINE programme and builds on the work done previously to analyse the challenges facing combined studies in Europe. COMBINE Project 2 aims to clarify how to apply the CTR, MDR and IVDR requirements on safety reporting in combined studies. The initial focus of the work was on understanding the respective requirements, timelines, and existing practices for reporting of serious adverse events, with a view on how to align the understanding of the different definitions of seriousness criteria and to give guidance to sponsors on how to handle the reporting requirements based on the investigator’s causality assessment. In addition, Project 2 provides a best practice guidance on the issues identified by stakeholders, including a diagram on information flow and communication across stakeholders. |
Is there a document which explians both, the eligibility criteria and the pilot proces?
Yes, the sponsor guide explains both.
How should a sponsor subit of an expression of interest?
Sponsors interested in participating in the COMBINE project 1 pilot should:
- complete the expression of interest form
- prepare the synopsis of the proposed combined study
- create an EMA account and request access to Eudralink to EMA’s service desk. Once granted access to Eudralink, users will be able to create packages to include all the requested documents
- submit the expression of interest form and protocol synopsis to EUcombinepilot@ccmo.nl, including Eudralink with the two documents (expression of interest form and protocol synopsis)
- if you already own an EMA account (username@id.ema.europa.eu) you need to modify this using your professional or personal email address.
Source: European Commission (eNews), European Commission