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Stefano Dettori

Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)

Stefano Dettori is the Director of IVD Operative Unit of Notified Body 0373 ISS. (2016 Responsible of IVD Operative Unit of NB 0373 ISS; 2011 Coordinator of IVD Operative Unit of NB 0373 ISS c/o infectious disease Department)

Since 12/11/2009 he worked in NB 0373 ISS as expert of IVD (Technical file reviewer and Auditor).

Since 02/1993 to 01/03/2017 he worked in Viral Hepatitis Unit of Infectious Disease Department (Istituto Superiore di Sanità), in the field of research on diagnostics, seroepidemiology, NAT, molecular characterization, studies about HCV, HBV, HGV, SENV, TTV;  and viral genome variability (41 scientific publication )

Graduated in  1995  in Biological Sciences at the University of “La Sapienza”, Rome.

 

1 blog from the author

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Regulation

Posted on 02.10.2018

IVDR: The designation issue during the transitional period

The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the three-year transition for the EU Medical Devices Regulation), the procedures to designate Notified Bodies (NBs) under each of these two regulations have started at the same time. NBs are […]

By Stefano Dettori Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)