EU report examines barriers to combined studies of drugs, IVDs, and devices

A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR) poses a challenge for sponsors conducting combined studies of different types of products subject to these regulations. Each regulation has different rules and criteria that apply to clinical research of medical products in the EU, according to a recent study released under the COMBINE initiative.

The report was developed with input from the European Commission, the national competent authorities, ethics committees, the European Medicines Agency (EMA), and other stakeholders.

The COMBINE project was launched in June 2023 to “address the growing number of challenges identified when conducting combined studies in Europe,” said a March 2024 presentation on the project released by the European Commission’s D.2 unit on medical products and the D.3 unit on medical devices.

According to the presentation, “Competent authorities in the field of clinical trials are receiving an increasing number of questions on how to handle the design and the submission of clinical trials involving candidate investigational medicinal products and medical devices/IVDs.” At the same time, it said that “competent authorities for medical devices have been receiving analogous questions.”

Combined studies can involve a clinical trial of a medicinal product in parallel with a performance study of an IVD, a clinical trial of a medicinal product in parallel with a clinical investigation of a medical device, or a clinical investigation of a medical device in parallel with a performance study for an IVD. The report also suggests that a combined study could theoretically involve a clinical trial of a medicinal product, a performance study of an IVD, and a clinical investigation of a medical device, though no such studies were identified in the development of the report.

The report notes that the CTR, IVDR, and MDR “contain requirements for the respective individual authorization for clinical trials, performance studies or clinical investigations. Combined studies are often conducted, providing important platforms to enable the availability of innovative and personalised treatments for patients in Europe.”

There were 343 applications for combined studies for the CTR and the IVDR, and out of these, 296 were for multinational studies. There were 59 applications for combined studies for the CTR and the MDR, and 43 of these were for multinational application.

Each of these regulations are “relatively recent and still undergoing their own implementation,” the report states. In addition, the report notes that “between the Regulations there are different rules and criteria which apply to clinical research of their respective health products; for example, there are different considerations to apply when determining if a CT [Clinical Trial], CI [Clinical Investigation] or PS [Performance Study] is required. In addition, the requirements, documentation, timelines and processes, as envisaged by the regulations, vary significantly between the CTR, IVDR and MDR. Conducting a combined study involves navigating all the requirements of each applicable Regulation and reconciling the differences between the same.”

Other highlights of the report: 61% of member states have established at least one ethics committee entity that can give an opinion on all three types of studies, which “shows there is a good basis for potential improvements to the system. In addition, 57% of member state competent authorities offer advice to sponsors of combined studies prior to application, and 36% of member states competent authorities offer pre submission meetings prior to the applications for combined studies, while 70% of these meetings are free.

A single ethics application can be made for combined studies in 14%, or four of the 28 Member States, and currently no Member State accepts a single competent authority application for combined studies which involve a clinical trial.

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EU report examines barriers to combined studies of drugs, IVDs, and devices

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