HM5/MD1/IVD1: COMBINE project: A new era of combined clinical trials in Europe
- Conducting clinical trials with drugs, medical devices (MDs) and in vitro (medical) devices (IVDs) in Europe is complicated because of overlapping regulations, for example, the Clinical Trial Regulation (CTR), the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) and differing national processes
- The COMBINE project aims to address these challenges by analysing regulatory issues and proposing solutions to streamline processes for combined studies
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