Developing and marketing a medical device combined with a medicinal substance requires an acute understanding from the manufacturer of its obligations and the requirements involved with putting such a device on the EU market. For a manufacturer, the key component would be to figure out how both the medicinal substance and the device work together. The regulatory framework to CE mark those types of devices is strictly defined. This webinar intends to discuss the different actors involved, the classification and the regulatory pathway existing for a manufacturer who wishes 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 required to be fulfilled for the different directives
• The actors and different aspects of the submission
• Understanding the classification of device-drug combination products
• The procedure for evaluation of Quality, Safety and Usefulness of medicinal substances ancillary to a medical device
• The guidance documents available