This tutorial will give a condensed overview of the medical device and in vitro diagnostics legislative systems, including the classification rules, the requirements for clinical investigations and the role of competent authorities and notified bodies at the development stage and for the conformity assessment. It will describe the current regulations with a focus on the differences with the coming new regulations on medical devices and in vitro diagnostics that are currently discussed at the European parliament. It will highlight potential challenges of the co-development of drug/medical device and drug/companion diagnostic products, illustrated with practical examples. Finally, some example of successful co-developments will be summarised with a focus on recently marketed drug/companion diagnostic products.
Who Should Attend
Professionals in the pharmaceutical area (regulatory affairs, clinical development) who are involved in the development and marketing of drug/medical device combinations or drug/companion diagnostics
At the conclusion of this tutorial, attendees will be able to:
- Understand the coming regulatory framework for drug/medical devices and drug/IVDs registration
- Estimate how the changes in the forthcoming regulations will impact current development projects in your company
- Implement good development practices in favour of a successful combination product/companion diagnostics development