Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis

• Published in: Clinical chemistry and laboratory medicine Vol. 60; no. 1; pp. 33 - 43
• Main Authors: Cobbaert, Christa, Capoluongo, Ettore D., Vanstapel, Florent J.L.A., Bossuyt, Patrick M.M., Bhattoa, Harjit Pal, Nissen, Peter Henrik, Orth, Matthias, Streichert, Thomas, Young, Ian S., Macintyre, Elizabeth, Fraser, Alan G., Neumaier, Michael
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 01.01.2022; Walter De Gruyter & Company
• Subjects: CA, National Competent Authority; CE, Conformité Européenne; CE-IVD tests; competent authorities; Contingency; Contingency plans; CS, Common Specifications; DG SANTE, Directorate-General for Health and Food Safety, European Commission; diagnostic directive 98/79/EC; diagnostic medical devices” for the European Commission; diagnostic regulation 2017/746; Diagnostic systems; diagnostic tests; EC, European Commission; EFLM, European Federation of Laboratory Medicine; EMA, European Medicines Agency; EPSCO, Employment, Social Policy, Health and Consumer Affairs; EQA, External Quality Assessment; EU regulatory system for IVDR implementation; EU, European Union; EUA, emergency use authorization; EUDAMED, European Databank on Medical Devices central monitored database in which economic operators, medical devices, UDI, Notified Bodies and certificates, vigilance and post-market surveillance, performance studies and market surveillance are included as a mandatory component of the IVDR; EURLs, European Union Reference Laboratories; European Commission; Expamed, Expert Panel; expert panel; FDA, Food and Drug Administration; in-house developed tests; IVDD; IVDR; IVDR 2017/746; IVDs; JRC, Joint Research Centre, the science and knowledge service of the European Commission; Laboratories; LDTs, lab developed tests or in house developed tests; MDCG, Medical Device Coordination Group that advises the EC and is composed of National Competent Authorities and attended by various stakeholders, including Biomed Alliance and EFLM; Medical innovations; NGS, next generation sequencing; notified bodies; QMS, quality management system; Risk analysis; RUO, research use only; SSP template, Summary of Safety and Performance template; STOA, Panel for the future of Science and Technology of the European Parliament; Supply chains; TGA, Therapeutic Goods Administration, an Australian Government Department of Health; competent authorities; in-house developed tests; CE-IVD tests; notified bodies; expert panel; European Commission; IVDR 2017/746; EU regulatory system for IVDR implementation
• ISSN: 1434-6621; 1437-4331
• DOI: 10.1515/cclm-2021-0975

Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC ( ) to IVDR 2017/746 . Without amendments and contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its “ ”.