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Papers matching “regulatory amendment” 4

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Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics
2025 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access

Christa M. Cobbaert, Christoph Buchta, Thomas Streichert, Florent J.L.A. Vanstapel, François Mullier, Lucas Biaggini, +5 more

12

citations
Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis
2021 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access

Christa M. Cobbaert, Ettore Capoluongo, Florent J.L.A. Vanstapel, Patrick M. Bossuyt, Harjit Pal Bhattoa, Peter H. Nissen, +6 more

26

citations
Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force
2022 HemaSphere article Health Professions Healthcare Regulation Open access

Isabel Dombrink, Bart R. Lubbers, Loredana Simulescu, Robin Doeswijk, Olga Yu. Tkachenko, Elisabeth M. C. Dequeker, +5 more

18

citations
Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities
2023 HemaSphere article Health Professions Healthcare Regulation Open access

Bart R. Lubbers, Isabel Dombrink, Tomáš Kalina, Mattias Hofmans, Morten Sichlau Bruun, Simon J. Stanworth, +5 more

5

citations

4 results