The current status of the transition to the MDR and IVDR regulations
by Giuliana Miglierini As the term to apply for the certification of medical devices and in vitro diagnostics…
MDCG, a position paper on the capacity of notified bodies
by Giuliana Miglierini The lack of a suitable capacity of notified bodies (NBs) is one of the main…
IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics
by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into…
ACT EU: the EU’s vision for the future of clinical trials
by Giuliana Miglierini Just few days before the entry into force of the new Clinical Trials Regulation and…