The challenges of combination products through the eyes of a newcomer

I would like to share the questions that have arisen in my mind as a newcomer over the past year regarding the European combination product regulation, mainly MDR Art. 117. I am afraid I will not offer clear answers:)

· Which is the competent authority – EMA or CA responsible for NB, it depends mainly on the question

· The shortcomings of soft law - EMA guides, MDCG guides and what else?

· The procedure around the NB opinion - it is a legal nightmare

· Primary packaging or device – interesting and shocking reactions from supplier’s side

· Significant change – who will decide, whi is responsible?

· NB opinion transfer – possibilities without clear rules