Endocrine Abstracts

In vitro diagnostics (IVD) in the European Union is facing a fundamental change with the introduction of a new regulation, the so-called In Vitro Diagnostics Regulation (IVDR). Originally, the IVDR was scheduled to enter into force in May 2022, however, in January 2022, the EU legislator made a differentiated partial postponement of the application of important parts of the IVDR. The major innovation and achievement of the IVDR is that most commercially manufactured IVD products must now be certified by independent (albeit commercial) notified bodies - replacing the system of self-certification by manufacturers. Notified bodies are under surveillance by member states. Because key regulatory processes have not been implemented in time, the entry into force of the IVDR for commercial IVDs has been delayed to 2025 to 2027, depending on the risk class. For the IVD industry, the product certification process requires significant additional resources for compliance. This may result in niche products being phased out of the market by some manufacturers. In addition to commercial products, some elements of the IVDR are also mandatory for in-house manufactured products, particularly Annex I (general safety and performance requirements), starting as early as May 2022, particularly for calibration and control materials and reagents manufactured in-house. The definition of in-house products in Article 2 (IVDR) does not include measurement methods, and the term LDT (laboratory developed test) is not used by the IVDR. Compliance with this regulation is not assessed at EU level, but is the responsibility of the Member States.