The IVD CE marking signifies that tests are registered for laboratory investigations, known as “in vitro diagnostic devices” in official terminology. The licensing and marketing of these devices are governed by each EU member state, based on EU regulations. In Hungary, where DualDur’s manufacturer is registered, this is governed by the “8/2003. (III.13.) ESZCSM Decree on in vitro diagnostic medical devices”.
According to this regulation, ‘IVD devices shall comply with the essential requirements described in Annex R. 1. The conformity of devices is checked and verified through different performance assessment procedures for various device groups. If the result of the performance assessment is positive, the device can be CE marked. IVD devices – … – can only be placed on the market and used with CE marking.’
Therefore, IVD CE registration requires a successful conformity assessment (performance evaluation) for all tests designed to detect diseases.
The DualDur IVD device registration and its clinical research were also managed by OGYÉI, the competent authority known as ‘The National Institute of Pharmacy and Nutrition’. The performance assessment involved three studies: an in-vitro performance assessment, a clinical trial to determine stability and detectability, and to check for artifact generation. The third study was the largest prospective clinical trial in Europe, involving 400 subjects across 8 sites in 6 countries. To date, this is the largest clinical trial in the field of Lyme disease diagnostics within the EU, with the research plan made publicly available in advance.
