Medical Devices Containing Ancillary Medicinal Substances

Manufacturers developing and marketing a medical device combined with a medicinal substance must acutely understand their obligations and the requirements for putting such a device on the EU market. Manufacturers must figure out how both the medicinal substance and the device work together as a key component. The regulatory framework strictly defines how to CE mark these types of devices. This webinar discusses the different actors involved, the classification, and the regulatory pathway that manufacturers must follow when they wish to introduce a medical device incorporating an ancillary medicinal substance on the EU market.

In this webinar, you will learn about:

• The key definitions and clauses you must fulfill for the different directives

• The actors and different aspects you encounter during submission

• How to classify device-drug combination products

• How authorities evaluate the Quality, Safety, and Usefulness of medicinal substances ancillary to a medical device

• The guidance documents you can access