I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily devices and those that are medicinal. This will even get harders with the adoption of new technologies such as bioelectronics because they could both diagnose and treat diseases and/or in combiation with other pharmaceutical components. Similar to what @srg36 has found, I also found the news about a new regulation being referenced in many different posts/journals to create consistency and uniformity in the assessment of medical devices. To me, it doesn’t seem like they want to create a product “filter type”, instead focus on the quality requirement of “Drug-Device-Combination”.

This is the link to the concept paper by EMA http://europa.eu/rapid/press-release_MEMO-17-848_en