The disparaging requirements of Article 5.5 of the IVDR for laboratories
Abstract
The timely provision of laboratory tests for infectious diseases is crucial for accurate diagnosis. However, the range of commercially available tests is limited and often does not meet sudden surges in demand. This gap poses a substantial risk not only to individual patients but also to public health. The COVID-19 pandemic has highlighted the necessity of laboratory developed tests (LDTs): the first test to detect SARS-CoV-2 was developed in an expert laboratory and formed the basis for many subsequent LDTs and commercial in vitro diagnostic devices (IVDs).
Fields of Study & Subjects
Scientific Measurement and Uncertainty Evaluation
Agricultural safety and regulations
Animal testing and alternatives
Publication details
- Journal / source
- The Lancet Microbe
- Publisher
- Elsevier BV
- Volume
- 7
- Issue
- 5
- Pages
- 101334–101334
- Publication date
- 7 January 2026
- Language
- EN