Regulatory awareness session on medical devices (Webinar)

Date: 02/12/2019
Location: European Medicines Agency, Amsterdam, the Netherlands

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.

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