Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

MDs incorporating ancillary medicinal substances  Regulation of medical devices ● NB / CA consultation ● Clinical trial notifications (CTNs) ● Overseeing notified bodies – CE marking – NBOp ● Post market surveillance/inspection ● Enforcement and prosecution

The Organisation for Professionals in Regulatory Affairs

25

EMA consultations

The Organisation for Professionals in Regulatory Affairs

26

13