Hi All,

As we all know, the US FDA handles Combination products according to their Primary Mode of Action (PMOA). For example, If the device PMOA is through chemical interaction, its approval process is handled through Center of Drug Evaluation and Research (CDER). In EU, the term combination product does not exist. Products are either considered a Medical Device or a Medicinal Product. Notified bodies usually face challenges when reviewing technical dossiers for combination products because they do not have a specific guideline to follow when reviewing these kinds of products. One example that I have seen notified bodies struggle with is prefilled syringes. These are considered combination products according to the FDA, but they are considered as just Medical Devices according to MDD.

Do you have experience with filing Combination products in EU? what is the major hurdles that you anticipate facing when filing for approval in EU?