2015, June

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.


Sam SHAKIR Certification Project Manager at LNE / G-MED North America, Inc.

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