I personally do not have any experience working in any industry. But from my understanding, I would imagine the company I work for would have either fall under FDA or EU. So under EU, the notified bodies will be filing the paperwork as they are experts and actually have power to inspect manufactures and audit the devices. They will be the best source of filing paper work for combination products. It would be unreasonable to rely on a single person to file paperwork for combination product without an expert’s opinion on classifying the product.