Regulatory awareness session on medical devices (Webinar)
This awarness session is organsied for medicine regulators in the European medicines regulatory network, with places available for non-EU regulators as well.
It will provide an update on the progress of EMA's implementation activities for Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices.
A guest speaker from the United States Food and Drug Administartion (FDA) will attend to provide a global perspective on current activities in this area.
The session will focus on:
- state of play of implementation of Medical Devices Regulation;
- drug-device combinations – the forthcoming quality guidance;
- a short journey into the emerging world of digital medicines;
- combination products – a view from the FDA.