Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics

The European COMBINE project aims to analyze the difficulties encountered by promoters in conducting combined studies and to identify solutions.

Clinical trial competent authorities and medical device competent authorities are receiving an increasing number of questions about how to manage the submission of clinical trials involving investigational medicinal products and medical devices/IVDs. The conduct of combined clinical studies in the EU is significantly delayed due to the complexity of the regulatory interaction between the Clinical Trials Regulation (CTR 536/2014) and the In Vitro Diagnostics Regulation (IVDR 2017/ 746) or the Medical Devices Regulation (MDR 2017/745). This subject worries health professionals who contacted the European Commission, which identified this subject as a priority during the EU ACT of June 2023.

For the development of innovative treatments that combine medicinal products with medical devices or IVDs, legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitrodiagnostics (IVDs) 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.

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 or a medical device.

The Member State’s competent authorities for clinical trials and medical devices and the European Commission launched the project COMBINE in June 2023. This 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 three strands of analysis:
1. collecting and analysing the challenges reported by various actors involved;
2. mapping relevant national processes and;
3. mapping already ongoing work in this area.

Based on this, a fourth work strand of work will make proposals for possible solutions to address the most important issues. The analysis was kicked off in September 2023 and is expected to be concluded by early 2024. The result of the first phase of the project will be a document describing the three aspects of analysis and the proposed solutions.

A second phase, from February 2024, should allow the possible development of solutions…

Here is the link to the project:

https://health.ec.europa.eu/system/files/2023-11/md_combined-studies_comb-prj-pres.pdf

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Since the arrival of Regulation 2017/745, new requirements are requested and form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR transition in its entirety.

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