Platomics announces new collaborations Read the Press Releases
Platomics announces new collaborations Read the Press Releases
26 May 2024 marked a major regulatory threshold for laboratories across Europe using in-house manufactured IVDs (IH-IVDs). While some obligations of Article 5(5) of the IVDR have been in effect since May 2022 – most notably the requirement to comply…
How Ongoing Education Keeps Your Lab Compliant, Competitive, and Ready for What’s Next The biomedical and diagnostic laboratory landscape is evolving rapidly. New technologies, stricter regulatory frameworks, and increased expectations around data integrity and quality assurance are reshaping how labs…
Understanding the difference will save your lab time and effort—and streamline compliance In a clinical laboratory, verification and validation are critical for ensuring the accuracy, reliability and compliance of diagnostic tests—and ultimately for ensuring patient safety. While the terms are…
Here’s what the standard can—and cannot—do for EU labs The recently released ISO 5649:2024 pulls together essential specifications for lab-developed tests to ensure they yield diagnostic results with optimal accuracy, effectiveness and safety. Regulatory experts tend to find standards beautiful,…
And how might the EU try to balance regulation and innovation? The past few weeks have seen some signs of the times regarding the fate of the IVDR (and its companion MDR): A VDGH conference asked in its very title…
Pipettes, centrifuges and the spin cycle of compliance General laboratory instruments, also known as GLUs (devices for General Laboratory Use), have a somewhat murky status under IVDR Article 5.5 requirements for labs. As with RUO devices, there is no “official”…
How labs might deliver on a rather tall order The IVDR has reshaped lab compliance and— let’s just admit it—put out a tall order for labs to serve up. One aspect that proves particularly exasperating is a much stronger emphasis…
The EC has now published an extended IVDR timeline that helps manufacturers but does little to ease the burden on labs. In the hopes of preventing a supply disruption of in vitro diagnostic medical devices for EU patients, the European…
Validation under ISO 15189 vs. performance evaluation under IVDR Before IVDR, many EU labs routinely validated their lab-developed tests in the course of following ISO 15189. And so the assumption may be that following the method validation approach of this…
The short answer: No, typically not We are often asked if it is enough for a lab to be ISO 15189 accredited to fulfill IVDR quality requirements. The short answer here is: No, it is not enough now that lab-developed…
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