During the certification process for devices with an ancillary medicinal substance, the Notified Body must review device aspects and seek the opinion of a European Competent Authority in relation to the ancillary medicinal substance incorporated in the device.
Prior to seeking the opinion of the Competent Authority, BSI must verify the usefulness of the medicinal substance incorporated in the device.
The Competent Authority will provide the Notified Body with a scientific opinion on the quality and safety of the substance taking in to account the clinical benefit/risk profile of the incorporation of the medicinal substance into the device.
The review of the medicinal substance by the Competent Authority may take up to 210 days and usually runs in parallel with the review of the device by the Notified Body.