Regulatory

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

1930 methods for scientific research application spearheads AI/ML pattern recognition predictive modeling in in vitro diagnostics 80 years later.

In the wake of the COVID-19 pandemic, the world continues to recover from disruptions in supply chain. Regardless of industry, companies have had to react in a timely manner, placing an emphasis on safe operations and ramping up supply of essential ingredients and materials to address the crisis, while some successfully pivoted into new product lines.

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

Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. Some of the most impactful changes include a new classification of IVDs, an expansion of post market surveillance and the increased need for Notified Body review. Most medical device manufacturers are aware that failure to meet In Vitro Diagnostic Regulation (IVDR) 2017/746 deadlines can result in either failure to obtain a CE marking or loss of a currently valid CE mark. The deadlines, however, are not written in stone.

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.

Have you struggled to develop your search strategies for the state of the art evaluation? Are you finding yourself sorting through large amounts of data? This article outlines best practices for creating the state of the art evaluation under EU regulations.