Daniel Wieser

Most of the regulatory debate over the past years has focused on manufacturers under the In Vitro Diagnostic Regulation (IVDR). For laboratories, however, one provision has always been central: Article 5(5), the in-house exemption. With the proposed revision of the…

In the fast-evolving world of diagnostic testing, many laboratories rely on in-house developed tests to meet specific patient needs. These tests, known as In-House IVDs (IH-IVDs) — sometimes also referred to as laboratory-developed tests (LDTs) — are essential for specialised…

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”…