HemoScreen IVDR Certification – A New Standard in Diagnostics

PixCell Medical is proud to announce that its groundbreaking HemoScreen CBC analyzer has achieved certification under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. As the only FDA-cleared, 5-part differential hematology analyzer for point-of-care use, HemoScreen’s IVDR certification represents a significant milestone in advancing hematology diagnostics and demonstrates PixCell Medical’s commitment to the highest standards of quality and patient safety.

IVDR Certification – Key Changes

The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 replaces the previous In Vitro Diagnostic Directive (IVDD) 98/79/EC, bringing substantial changes to the regulatory framework for in vitro diagnostic devices in the European Union.

One of the most notable updates is the IVDR’s risk-based classification system, which categorizes devices into four classes—A, B, C, and D—based on the level of risk. Under this framework, the majority of IVDs, approximately 80-90%, now require certification by a Notified Body. This marks a dramatic shift from the IVDD, where only about 20% of devices required such certification. Self-certification is now limited to non-sterile Class A devices, making the path to market more demanding for manufacturers.

Additional changes introduced by the IVDR include:

• Enhanced post-market surveillance requirements to ensure ongoing monitoring of device safety and performance.
• Inclusion of software and Lab-Developed Tests (LDTs) under regulatory oversight, aligning these products with stricter compliance standards.
• Comprehensive CE certification requirements, mandate that most IVDs undergo assessment by independent Notified Bodies before market entry.

HemoScreen IVDR Compliance

HemoScreen’s successful IVDR certification underscores PixCell Medical’s proactive approach to navigating the evolving regulatory landscape. Completing the rigorous certification process years ahead of the mandated deadlines, this achievement highlights the device’s exceptional clinical performance, safety, and utility in diverse healthcare environments.

Backed by extensive clinical studies, HemoScreen delivers lab-accurate diagnostic results at the point of care, using just a single drop of blood and minimal training. Its patented disposable cartridges, integrated reagents, and AI-powered machine vision technology enable rapid and reliable CBC analysis in a variety of medical settings, including clinics, emergency rooms, and remote locations.

By meeting the IVDR’s demanding standards, HemoScreen has further solidified its position as a trusted diagnostic tool for healthcare providers worldwide. This milestone exemplifies PixCell Medical’s dedication to quality and innovation and sets a benchmark for proactive compliance in the ever-evolving field of diagnostic technology.

Read the latest press release announcing this regulatory milestone here.

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