IMDRF 2023

Silvia Ostuni is a Legal and Policy Officer at the European Commission’s unit for Medical Devices in the Directorate General for Health and Food Safety (DG SANTE).

In her team, and in the context of the implementation of the new EU medical devices Regulations, Silvia is responsible for the Unique Device Identification (UDI) system of devices and chairs the Medical Device Coordination Group (MDCG) on UDI.

Silvia has also experience in the implementation of EU IT systems, and as such she has a key role in the development of the European Database on Medical Devices (EUDAMED) and for the legal aspects around it.

She is responsible for the drafting of MDCG guidance documents and EU tertiary legislation on those topics and is on the team for the EU’s chairmanship of the IMDRF in 2023.

Silvia has a master’s degree in law and a LL.M. in Law and Government of the European Union.