Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but such issues tend to be persistent, said Rachel Gibbs, principal regulatory consultant at NAMSA, during this year’s RAPS Euro Convergence meeting in Amsterdam.
Beyond her current role at NAMSA, where she advises companies on how to comply with notified body requirements, Gibbs also has experience as an auditor for the British Standards Institution (BSI).
“The purpose obviously of an SSCP is transparency … providing clinicians with the information to make the appropriate clinical decisions and providing patients with that information so they can make informed decisions on whether they want to pursue a certain treatment,” she said during an 11 May session on SSCP best practices.
Gibbs added that the SSCP is supposed to be reviewed and published to the European Union’s EUDAMED database by notified bodies, but manufacturers are also supposed to post them on their company website. They also need to ensure the information provided in the SSCP matches up with information available in other databases…
