Regulatory Divergence Presents Barriers To EU Combined Studies

The European Union's (EU) regulatory landscape for medical devices and in vitro diagnostics (IVDs) has become increasingly complex, particularly for sponsors conducting combined studies. These studies, involving simultaneous clinical investigations of a medicinal product and a medical device or IVD, face significant challenges due to the lack of alignment between the Clinical Trial Regulation (CTR), Medical Devices Regulation (MDR), and In-Vitro Diagnostic Medical Devices Regulation (IVDR).

Sponsors must navigate separate approval processes, deal with multiple regulatory authorities, and contend with the absence of a coordinated assessment system. The ongoing development of the European-wide medical device database (EUDAMED) offers hope for future improvements, but significant delays and limitations currently hinder progress.

The COMBINE project, a collaborative effort to address these challenges, has proposed solutions such as a coordinated assessment for clinical investigations and performance studies. However, industry stakeholders express concerns about the limited scope of the initial pilot phase and the ongoing barriers to conducting combined studies in the EU.

Learn more about the specific challenges and potential solutions in the full article.