New guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies

A new guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies is now available.

Belgium now offers a synchronised procedure for combined studies. These are clinical trials involving medicinal products combined with a corresponding performance study or a clinical investigation involving medical devices or in vitro diagnostic medical devices.

This Belgian approach aligns the timelines of both submission procedures, making it easier and more efficient for sponsors to submit their applications. A new guidance for sponsors is now available, containing detailed information on the procedures.

Separate and independent assessments

The assessments of the studies remain separate and independent, but questions and requests for further information are better aligned.

This helps to ensure:

- fewer duplicate or overlapping questions;

- less need for additional corrective submissions;

- a smoother overall assessment process.

The procedure applies to most national and multinational combined studies requiring authorisation under both the Clinical Trials Regulation (CTR) and the Belgian procedure for a consolidated opinion on medical devices (MDR) and in vitro diagnostic medical devices (IVDR).

More info

Guidance for sponsors