Giovanni Campana
Giovanni Campana is Global RA CMC Director Medical Devices & Injectors, UCB, with a specific track record in the development, registration and quality management (QMS) of Medical Device / Combination Products.
JournalOne year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products
Since 26 May 2021, Article 117 of the MDR asks for a notified body opinion (NBOp) to be included in the marketing authorisation applications (MAAs) for medicinal products that are a single integral drug-device combination.