From compliance to complexity: the impact of in vitro diagnostic regulation for clinical microbiology laboratories

OBJECTIVES: The implementation of the European in vitro medical devices regulation (IVDR) poses significant challenges, yet its impact has not previously been quantified in clinical microbiology. The aim of this study was to quantify the number of tests in a large clinical microbiology laboratory that may be affected by IVDR. METHODS: The study was performed in a clinical microbiology laboratory of a large academic hospital in the Netherlands. We calculated proportion of CE-marked tests and laboratory-developed tests (LDTs), and we calculated the number of test results generated by these tests. RESULTS: We found that CE-IVD-labelled tests accounted for 55% (57/104) of the available tests in bacteriology but represented 82.8% (99 521/120 254) of all test results generated in this specialty. Among tests in mycology, 38% (6/16) were LDTs. Most LDTs were PCR assays targeting specific microorganisms, such as Bordetella spp. and Candida auris. In contrast, only 29% (7/24) of parasitology tests had a CE-IVD label, and these accounted for 38.3% (1612/4209) of all test results in this specialty. CONCLUSIONS: We showed the potential burden in complying with IVDR 2017/746 in a clinical microbiology laboratory and the need for LDTs in certain setting. The results of this study may initiate informed discussion on a balanced implementation of the IVDR, ensuring compliance while minimizing unnecessary burden for clinical microbiology laboratories and also manufacturers.