Structure and content of the EU-IVDR

[1]  C. Meisel,et al.  Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]) , 2021, Therapeutic Innovation & Regulatory Science.

[2]  W. Weichert,et al.  Einfluss der neuen In-vitro-Diagnostik-Regulation (IVDR) der Europäischen Union auf die Pathologie. Was ist wichtig? , 2020, Der Pathologe.

[3]  B. Tops,et al.  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 complications , 2020, Clinical chemistry and laboratory medicine.

[4]  E. Dequeker,et al.  The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care , 2020, Clinical chemistry and laboratory medicine.

[5]  Marina N Nikiforova,et al.  Guidelines for Validation of Next-Generation Sequencing-Based Oncology Panels: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists. , 2017, The Journal of molecular diagnostics : JMD.

[6]  Samuel P. Strom Current practices and guidelines for clinical next-generation sequencing oncology testing@@@Current practices and guidelines for clinical next-generation sequencing oncology testing , 2016 .