EMA Q&A Addresses Devices and Integrated Medicines

An EMA Q&A document provides advice on how to develop medical devices that incorporate a medicinal substance or an in vitro diagnostic.

For medical devices that form an integral product with a medicinal product, developers are now required to provide an EU declaration of conformity, a certificate of conformity, or an opinion from a notified body designated for the type of device in question are applicable in certain circumstances.

Read the Q&A here.

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