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…
Reactions to the proposed ban of PFAS
by Giuliana Miglierini A proposal to ban around 10,000 per- and polyfluoroalkyl substances (PFAS) was submitted in January…
The Interface between Pharmaceutical Products and Medical Devices from a Product Development perspective
EIPG webinar Next EIPG webinar is to be held on Monday 26th of June 2023 at 17.00 CEST…
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 OMS has turned mandatory for centrally authorised products
by Giuliana Miglierini Since November 1st, 2021, the use of the Organisation Management Service (OMS) became mandatory for…
Steps forward towards the new framework for HTA
By Giuliana Miglierini The long-waited European regulation on Health Technology Assessment (HTA) was adopted by the Council of…