Hi Fady!

I do not have experience with filing combination products in the EU. However, in my opinion, it seems like a major hurdle would be choosing a Notified Body that is capable of evaluating combination products and completing paperwork associated with the conformity of the product before being placed on the market. The evaluation by a Notified Body of combination products needs to include an opinion of a competent authority. The regulatory review and approval process for combination products is certainly complex because it can take several months to achieve.