Navigating Drug Clinical Trials with Medical Devices and In-Vitro Diagnostics: Compliance with MDR/IVDR and CTR
EducationalTHE NEXT FRONTIER IN COMBINATION PRODUCTS
2026-05-28 | 10:00 AM - 10:15 AM | TPD Room
Abstract
This presentation provides an overview of the types of medical devices used in drug clinical trials and outline the corresponding regulatory pathways.
It will explain the requirements for developing medicinal products in combination with in-vitro diagnostics (IVDs), including companion diagnostics (CDx), under the IVDR. The session will also address combined studies and the interface between the Clinical Trials Regulation (EU) 536/2014 (CTR) and the MDR/IVDR.
Key challenges will be highlighted, along with an update on the Combine Project.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
• Type of devices used in drug clinical trial
• Regulatory pathway
• Development of medicinal products in combination with an IVDs (CDx) under IVDR requirements.
• Combined studies
- Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and medical device regulations (EU) MDR/IVDR
- Challenges
• Update on Combine Project
