European Medicines Agency publishes public assessment reports for ancillary medicinal substances included in medical devices

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08/08/2012

European Medicines Agency publishes public assessment reports for ancillary medicinal substances included in medical devices

The European Medicines Agency has started publishing public assessment reports for ancillary substances included in medical devices.

The Agency has no responsibility for the regulation of medical devices. However, when a medical device contains a medicinal product as an ancillary substance, the Agency is asked to provide a scientific opinion on the medicinal substance to a notified body, an organisation accredited by a Member State to assess whether a medical device meets certain preordained standards. The scientific opinion addresses the quality and safety of the medicinal substance including the clinical benefit/risk profile of the incorporation of the substance into the device.

Since 2005, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has given nine scientific opinions on ancillary substances. In a move to further increase transparency, the Agency has now published the public assessment reports for all nine substances.

In the future, the Agency will publish public assessment reports for all scientific opinion on ancillary substances.

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info@ema.europa.eu