Regulations on devices, diagnostics, and trials are ‘misaligned,’ says EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said the “misalignment” between diagnostics and medical devices regulations and the Clinical Trials Regulation (CTR) is discouraging investment and impacting patient access to advanced therapies.

The industry group outlined its concerns in a letter in March in response to a European Commission request for feedback about regulations 2017/745 and 2017/746, which cover medical devices and in vitro diagnostics, respectively.

“Both regulations, while aiming to ensure availability of high-quality devices, have created regulatory complexity, increased administrative burdens, and introduced misalignment with the CTR, resulting in delays in patient access to innovation.

One of the examples the EFPIA provides relates to the lack of integration between submission processes for devices, diagnostics, and trials, which the group said could be managed more effectively, citing the COMBINE project as a potential model.

“The commission should implement an “all-in-one” coordination process, building on the COMBINE project, to centralize and integrate the submission and assessment process for clinical investigations/performance studies and clinical trials applications,” the EFPIA wrote.

Such a process would minimize regulatory fragmentation, reduce work duplication, and improve efficiency, according to the EFPIA, which also suggested the approach would ensure the coordination of ethics committees.

The commission should also make implementation of the Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, and CTR more consistent in EU member states, according to the EFPIA, which suggested that standardized education, training, and review processes would help.

In particular, the organization says regulator training related to the assessment of applications for clinical investigations, performance studies, and clinical trials would be beneficial.

The EFPIA also called on the commission to accelerate the deployment of the EU database on medical devices to support the coordinated assessment of performance studies and clinical investigations and allow the efficient approval of combined trials.

Unsplash/Wesley Tingey