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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation2023 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Florent J.L.A. Vanstapel, Matthias Orth, Thomas Streichert, Ettore Capoluongo, Wytze P. Oosterhuis, Hikmet Can Çubukçu, +10 more
46citations -
Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project2025 The Lancet Regional Health - Europe article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Sergio Buccheri, Robert A. Byrne, Per Kjærsgaard‐Andersen, Stefan Karl James, Peter Jüni, +87 more
12citations -
Reference, calibration and referral laboratories – a look at current European provisions and beyond2024 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Christoph Buchta, Bernhard Benka, Vincent Delatour, Ingrid Faé, Andrea Griesmacher, Karina Hellbert, +9 more
7citations -
Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis2021 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
26citations -
Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics2025 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
12citations -
Pan-European Study on Functional and Medical Recovery and Geriatric Rehabilitation Services of Post-COVID-19 Patients: Protocol of the EU-COGER Study2021 The journal of nutrition health & aging article Health Professions Medical Practices and Rehabilitation Open access
Stefan Grund, Monique A. A. Caljouw, Miriam L. Haaksma, Adam Lee Gordon, Romke van Balen, Jürgen Martin Bauer, +2 more
14citations -
Compatibility of the CEN-ISO/TS 82304-2 Health App Assessment Framework With Catalan and Italian Health Authorities’ Needs: Qualitative Interview Study2025 JMIR Formative Research article Health Professions Mobile Health and mHealth Applications Open access
Petra Hoogendoorn, Mariam Shokralla, Romy Fleur Willemsen, Nick Guldemond, María José Villalobos-Quesada
2citations -
Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee2024 European Heart Journal - Digital Health article Health Professions Mobile Health and mHealth Applications Open access
Enrico Gianluca Caiani, Hareld Kemps, Petra Hoogendoorn, Riccardo Asteggiano, Allan Böhm, Britt Borregaard, +18 more
32citations -
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)2021 European Heart Journal - Quality of Care and Clinical Outcomes article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Rob G. H. H. Nelissen, Per Kjærsgaard‐Andersen, Piotr Szymański, Tom Melvin, Paul Piscoi, +80 more
35citations -
Empowering regulatory science for medical devices in Europe2026 The Lancet Regional Health - Europe article Health Professions Healthcare Regulation Open access
Alan G. Fraser, Robert A. Byrne, Elisabeth M. C. Dequeker, Per Kjærsgaard‐Andersen, Sanja Kolaček, Tom Melvin (16298975), +3 more
0citations -
What Makes a Quality Health App—Developing a Global Research-Based Health App Quality Assessment Framework for CEN-ISO/TS 82304-2: Delphi Study2022 JMIR Formative Research article Health Professions Mobile Health and mHealth Applications Open access
Petra Hoogendoorn, Anke Versluis, Sanne Christine van Kampen, Charles McCay, Matt Leahy, Marlou Bijlsma, +23 more
34citations -
Integrating CEN ISO/TS 82304-2 in the Catalan Health App Assessment Framework: Comparative Case Study2025 JMIR mhealth and uhealth article Health Professions Mobile Health and mHealth Applications Open access
Berta Llebot Casajuana, Petra Hoogendoorn, María José Villalobos-Quesada, Carme Pratdepàdua Bufill
4citations -
The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications2020 Clinical Chemistry and Laboratory Medicine (CCLM) article Health Professions Healthcare Regulation Open access
Paul C. D. Bank, Leo H.J. Jacobs, Sjoerd A.A. van den Berg, Hanneke W. M. van Deutekom, Dörte Hamann, Richard Molenkamp, +6 more
48citations -
Question‐based development of high‐risk medical devices: A proposal for a structured design and review process2023 British Journal of Clinical Pharmacology article Health Professions Healthcare Regulation Open access
Nicholas A. White, Timo J. C. Oude Vrielink, Koen E.A. van der Bogt, Adam F. Cohen, Joris I. Rotmans, Tim Horeman
7citations -
Data Resource Profile: Extramural Leiden University Medical Center Academic Network (ELAN)2024 International Journal of Epidemiology article Health Professions Medical Coding and Health Information Open access
Janet M Kist, Hedwig M. M. Vos, Rimke Cathelijne Vos, Albert T.A. Mairuhu, Jeroen Nathan Struijs, Robert R. J. M. Vermeiren, +10 more
25citations
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