{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T02:10:40Z","timestamp":1778119840876,"version":"3.51.4"},"reference-count":22,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T00:00:00Z","timestamp":1694390400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes IVDR regulation risky, because its detrimental effect on production of in-house tests will negatively impact knowledge and expertise in the development of new diagnostic tests. Moreover, such regulations negatively impact the availability of diagnostic tests, especially for neglected pathogens, and has a detrimental effect on the overall costs of the tests. The increased regulatory burden of IVDR may thereby pose an important risk for public health. Taken together, it will have a negative impact on the financial balance of diagnostic microbiology laboratories (especially small ones). The already-high standards of quality management of all ISO-accredited and Swissmedic-authorized laboratories render IVDR law of little value, at least in Switzerland, while tremendously increasing the regulatory burden and associated costs. Eventually, patients will need to pay for diagnostic assays outside of the framework of their insurance in order to obtain a proper diagnostic assessment, which may result in social inequity. Thus, based on the risk assessment outlined above, the coordinated commission for clinical microbiology proposes adjusting the IvDO ordinance by (i) introducing an obligation to be ISO 15189 accredited and (ii) not implementing the IvDO 2028 milestone.<\/jats:p>","DOI":"10.3390\/diagnostics13182910","type":"journal-article","created":{"date-parts":[[2023,9,11]],"date-time":"2023-09-11T09:05:17Z","timestamp":1694423117000},"page":"2910","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9481-9778","authenticated-orcid":false,"given":"Alix","family":"Coste","sequence":"first","affiliation":[{"name":"Institute of Microbiology, University of Lausanne & University Hospital Center, 1011 Lausanne, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Egli","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology, University of Zurich, 8006 Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jacques","family":"Schrenzel","sequence":"additional","affiliation":[{"name":"Bacteriology Laboratory, Service of Laboratory Medicine, Department of Diagnostic, Geneva University Hospitals, 1211 Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2732-2643","authenticated-orcid":false,"given":"Beatrice","family":"Nickel","sequence":"additional","affiliation":[{"name":"Swiss Tropical and Public Health Institute, 4123 Allschwil, Switzerland"},{"name":"University of Basel, 4002 Basel, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Zbinden","sequence":"additional","affiliation":[{"name":"Institute of Medical Microbiology, University of Zurich, 8006 Zurich, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reto","family":"Lienhard","sequence":"additional","affiliation":[{"name":"ADMed Microbiologie Laboratory, 2300 La Chaux-de-Fonds, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexis","family":"Dumoulin","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Institut Central des H\u00f4pitaux, H\u00f4pital du Valais, 1950 Sion, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Risch","sequence":"additional","affiliation":[{"name":"Dr Risch Medical Laboratory, Wuhrstrasse 14, 9490 Vaduz, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9529-3317","authenticated-orcid":false,"given":"Gilbert","family":"Greub","sequence":"additional","affiliation":[{"name":"Institute of Microbiology, University of Lausanne & University Hospital Center, 1011 Lausanne, Switzerland"},{"name":"Infectious Disease Service, University of Lausanne & University Hospital Center, 1011 Lausanne, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,11]]},"reference":[{"key":"ref_1","unstructured":"European Union (2023, July 01). In vitro Diagnostic regulation. Available online: https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj."},{"key":"ref_2","unstructured":"The Swiss Federal Council (2023, July 01). Ordinance on In Vitro Diagnostic Medical Devices (IvDO). Available online: https:\/\/www.fedlex.admin.ch\/filestore\/fedlex.data.admin.ch\/eli\/cc\/2022\/291\/20220526\/en\/doc\/fedlex-data-admin-ch-eli-cc-2022-291-20220526-en-doc.doc."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Kahles, A., Goldschmid, H., Volckmar, A.L., Ploeger, C., Kazdal, D., Penzel, R., Budczies, J., Kempny, G., and Kazmierczak, M. (2023). Structure and content of the EU-IVDR: Current status and implications for pathology. Pathologie, 1\u201313.","DOI":"10.1007\/s00292-022-01176-z"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1515\/cclm-2020-1384","article-title":"The end of the laboratory developed test as we know it? 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