Clinical literature reviews are critical components to achieving MDR compliance. Review of scientific literature may be needed for many EU MDR deliverables.

This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations.

Medical device literature reviews for EU CERs present a challenge to many manufacturers. The literature review component of your CER will undergo robust scrutiny by the Notified Bodies.

The claims a manufacturer chooses to make about its medical device are an important aspect of the product and are closely tied to its safe use and optimal performance.

When a manufacturer desires to make a change to a Class III device that has been approved via a Premarket Approval (PMA) or product development protocol (PDP) that affects the device’s safety and effectiveness (new indication for use, a change to the labeling, new manufacturing site, etc.) or a change to a Humanitarian Device Exemption (HDE) that affects its safety and probable benefit, a supplement application is required.