Daniel Wieser

Rethinking IVDR Technical Documentation – Part 2 of 4 Introduction IVDR technical documentation is more than a collection of files. In this four-part series, we examine how digitalization can make regulatory information more actionable, maintainable, and suitable for responsible automation. Part 2…

Rethinking IVDR Technical Documentation – Part 1 of 4 Introduction IVDR technical documentation is more than a collection of documents. It is a continuously evolving body of regulatory information that must remain complete, consistent, and traceable throughout the device lifecycle. In…

Have you ever looked around a diagnostic laboratory and wondered what all those CE marks actually mean?  The same CE symbol may appear on an IVD analyzer, a centrifuge, an RUO sequencer, a Bluetooth-enabled reader, a reagent kit or even a battery. The logo…

With the implementation of the In Vitro Diagnostic Regulation (IVDR), laboratories across Europe are facing new regulatory expectations. One of the most important areas concerns in-house IVDs, a concept that allows health institutions to develop or modify diagnostic tests internally…

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,…