Clinical evaluation for a consumer health company
The consumer health subsidiary of a leading Global pharma company, whose portfolio also included several medical devices, contacted SFL for support with clinical evaluation for one of its medical devices. The concerned device contained an ancillary medicinal substance and during its assessment, the competent authority had requested the clinical evaluation be updated in accordance with the current guidelines.
SFL’s experience writing clinical evaluation reports (CERs) according to MEDDEV 2.7.1 enabled a smooth interaction with the client and delivery of a high-quality document within the required timelines, and conforming to the competent authority’s wishes.
The project involved an extensive systematic literature search to identify clinical data on the device and the medicinal substance. Following this, SFL incorporated all published clinical data and other source reports provided by the client (clinical study reports, risk management documentation, post-market surveillance) to provide a document allowing conclusions on the benefit-risk ratio of the device to be drawn. The report was accepted without further changes by both the notified body and the competent authority.
SFL subsequently received several other projects from the same client, including revision of other CERs, as well as classification of other drug/device combinations which the company was considering in-licensing.