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Proscia’s Cocentriq Scores IVDR

This new regulatory framework replaces the IVD Directive, under which Concentriq Dx also received a CE mark.

MDDI Staff

June 8, 2022

2 Min Read
black board with the words "New Regulation" and "This has changed!"
Image courtesy of palatiaphoto / Alamy Stock Photo

Proscia said its Concentriq Dx platform has been certified under the new In Vitro Diagnostic Regulation (IVDR) for use in primary diagnosis.

The IVDR certification demonstrates that Concentriq Dx complies with the stronger quality and safety standards that now govern in vitro diagnostic medical devices in the European Union. This new regulatory framework replaces the IVD Directive, under which Concentriq Dx also received a CE mark.

“Proscia’s dedication to quality is unwavering,” said Kim Rendon, director of regulatory affairs at Proscia. “The IVDR certification is a testament to our focus on delivering the safe, efficacious solutions that pathologists need to provide faster, more accurate diagnoses and ultimately improve patient outcomes.”

A singular, secure platform, Concentriq Dx helps shift the standard of care from microscope to image. It combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks. As laboratories increasingly look to unlock new insights with computational solutions, Concentriq Dx is designed to support them in realizing pathology’s AI-enabled future.

While the EU Commission's new Medical Device Regulation (MDR) has drawn considerable criticism from industry, complying with the EU IVDR might be less burdensome than previously thought.

A recently-published white paper from RQM+, a regulatory, quality, and clinical consulting firm, spotlights synergies between the EU Commission's IVDR requirements and the requirements of FDA in the United States.

“The EU Commission’s recent approved proposal means a sigh of relief for some IVD manufacturers with existing directive products on the market. It does not change the date of application, but allows for a progressive roll-out to the IVDR based on device classification, with a shorter timeframe for higher risk devices," said Carlos Galamba, vice president of IVD intelligence and innovation at RQM+, and author of the paper.

However, there is no room for complacency, he warns.

"Notified Bodies will not engage with companies unless their technical documentation, including performancedata is complete. I cannot stress enough how important it is for IVD manufacturers to review whether they have enough clinical evidence, to give themselves enough time to take remedial action," Galamba said. "We hope that this new paper will help manufacturers to plan efficiently for compliance, by making full use of what is already available.”

Read more about Galamba's paper here.

 

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