I do not have any experience, but I found an article about the regulatory pathways of drug-device and device-drug combination products on the EU from the NSF. In the key points, they clearly state that it is critical to understand the main mode of action of the product since that will determine whether it will be regulated as a medical device or as a medicinal product in the EU. If it is a Drug-Device Combination, then medicinal product has the primary mode of action and the design dossier is evaluated by the European Medicines Agency (EMA) which is an expensive regulatory process. If it is a device-drug combination the main authority is the Notified Body and they are usually classifies as class III MD, if the device-drug combination involves blood then EMA consultation is mandatory and if unfavorable opinion is given by EMA to the notified body, then the notified body cannot issue a CE mark. There is more information that can be useful so the link for this document is: http://www.nsf.org/newsroom_pdf/md_regulatory_pathways_j31.pdf