A study on the reprocessing and reusing of single-use devices
by Giuliana Miglierini Reprocessing and reusing are one of the key actions central to many new EU policies…
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…
Review of the pharmaceutical legislation, the proposals of the industrial associations
By Giuliana Miglierini The Staff Working Document on “Vulnerabilities of the global supply chains of medicines” published by…
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…
EMA’s Industry stakeholders group (ISG)
by Giuliana Miglierini The Industrial Stakeholder Group (ISG) is a new initiative recently launched by the European Medicines…
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…