Drug device combination products and substance-based medical devices
Sep 14 | Copenhagen, Denmark
Medicon Valley Alliance, together with member company Innokas Medical, have the pleasure to invite you to the Medicon Valley Alliance MedTech Network meeting, on the 14th of September, focusing on drug-device combination products and substance-based medical devices.
The market for drug-device combination products is growing and it is anticipated that up to one in three medical products in development is a combination of a drug/substance and a MedTech product. Drivers for the growth in combination products is the rise of patients suffering from chronic diseases such as diabetes, cancer, and respiratory problems as well as growth in the home-based health care market and technological advancements.
When searching for the correct regulatory approval in the EU the primary mode of action (PMOA) will define the regulatory path for your products. For example, if the action of your medicinal substance is ancillary, then your product is regulated as a medical device under MDR, on the other hand, if the product is mainly of the medicinal substance the product will be regulated as a medicinal product. A substance with a therapeutic effect can be either a medicinal product/drug or a medical device, depending on its primary mechanism of action.
Developing this type of products is associated with a high level of complexity. For combination products, you need to navigate two of the most intensely regulated pathways in one go: for pharmaceuticals and medical devices. The re-classification of substance-based medical devices according to MDR means a more extensive risk assessment involving scientific evidence of PMOA.
In this MVA MedTech Network meeting, we would like to invite you to hear from experts in the area of developing drug-device combination products and substance-based medical devices as well as hearing from companies sharing their experiences, challenges and solutions.
If you are interested in sharing your company’s approach and experiences with drug-device combination products and/or substance-based medical devices and to speak at the meeting on the 14th of September, please reach out to Sofia Norås, firstname.lastname@example.org.