Module 18 2021

07/02/2021

The CTD .. Where would you put the device information?

The Organisation for Professionals in Regulatory Affairs

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Information on device component Module 3, European Community Additional Information — Medical Device — Certificate(s) of Suitability

Where applicable and if needed, a CE marking which is required by Community legislation on medical devices shall be provided. “… supplemented by any relevant data concerning the type of container and, where appropriate, its manner of closure, together with details of devices with which the medicinal product will be used or administered and which will be delivered with the medicinal produc t ”

The Organisation for Professionals in Regulatory Affairs

40

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