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Journal articles on the topic 'IVDR'

Author: Grafiati

Published: 30 June 2021

Last updated: 29 July 2025

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1

Nayak, Shashank, M. P. Venkatesh, and Pramod Kumar T.M. "EU IVDR Regulatory Changes: An Overview of Requirements in (EU) 2017/746." Applied Clinical Research, Clinical Trials and Regulatory Affairs 7, no. 3 (2020): 237–43. http://dx.doi.org/10.2174/2213476x07666200327143023.

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IVDR is the new regulatory basis for placing IVDs in the market, making them available and putting them into service in the European market. EU IVDR regulation is much bigger than the impact of EU IVDD, which is a bold statement to make, considering the significant industry- wide impact as it presents challenges to the manufacturer. Rather, it is largely a revision that contains guidance on how to fulfill the existing IVDD requirements. IVDR focused on the IVD-specific provisions therein regarding classification, performance evaluations, clinical data, conformity assessments and notified bodie

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Du, Zhenya, Fusheng Chen, Kunlun Liu, et al. "Effects of Extruded Soy Protein on the Quality of Chinese Steamed Bread." Journal of Chemistry 2016 (2016): 1–8. http://dx.doi.org/10.1155/2016/3691523.

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Five different extruded soy protein isolates (ESPIs) were obtained by extrusion and denoted by IVD1, IVD2, IVD3, IVD4, and IVD5. Then the SDS-PAGE results showed that the subunits of SPI decreased after extrusion, especially the subunits of 90.8, 32.8, and 31.3 kDa, whereas no isopeptide bond was formed. Although SPI improved both the development time (DT) and stability (S) of dough, ESPIs increasedSbut the DT decreased from 4.3 min to 1.8–2.0 min. Texture profile analysis (TPA) results showed that the hardness and chewiness of Chinese steamed bread (CSB) decreased in the order wheat flour+IVD

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3

Naga Gouri T, Venkatesh M P, Balamuralidhara V, and Pramod Kumar T M. "A futuristic study on in-vitro medical devices regulations." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (2020): 2221–27. http://dx.doi.org/10.26452/ijrps.v11i2.2173.

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The In-Vitro Medical Devices Directive (IVDD) established in 1998 by the European Union met the requirements of the single medical device market. In the due course, IVDD could not regulate all new technical and medical developments in the sector. The IVDD 98/79/EC, was preceded with IVDR 2017//746; which defined and demonstrated conformity to essential requirements, established harmonized standards and facilitated the organization of ‘Notified Body’ (NB), Competent Authority oversight and market surveillance. IVDR implemented streamlines as defined in Annex I of the EU IVDR 2017/746 conforming

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4

Coste, Alix T., Adrian Egli, Jacques Schrenzel, et al. "IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland." Diagnostics 13, no. 18 (2023): 2910. http://dx.doi.org/10.3390/diagnostics13182910.

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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

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5

Jacobs, Leo. "IVDR." Laboratoriumgeneeskunde 3, no. 5 (2020): 6. http://dx.doi.org/10.24078/labgeneeskunde.2020.10.126050.

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6

Wollenhaupt, Clara, Thomas Sudhop, and Werner Knoess. "A Systematic Database Approach to Identify Companion Diagnostic Testing in Clinical Trials under the New In Vitro Diagnostic Medical Devices Regulation." Diagnostics 13, no. 12 (2023): 2037. http://dx.doi.org/10.3390/diagnostics13122037.

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The European Union In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) introduces companion diagnostics (CDx) as a new legal term. CDx are applied in combination with a medicinal product to identify patient subgroups most likely to benefit from a treatment or who are at increased risk. This new regulation came into full effect on 26 May 2022 and represents the current development in personalized medicine. The implementation of IVDR and CDx is a regulatory challenge in the EU, requiring re-assessment of in vitro diagnostic medical devices (IVD) in terms of their CDx designation.

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Kugiya, F., H. Nishida, A. Saitou, and N. Kodama. "iVDR business perspective." Journal of Magnetism and Magnetic Materials 320, no. 22 (2008): 2894–99. http://dx.doi.org/10.1016/j.jmmm.2008.07.043.

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8

Sucker, Christoph, Günther Kappert, and Jürgen Koscielny. "Ablösung der In-Vitro-Diagnostika-Richtlinie auf die In-Vitro-Diagnostika-Verordnung (IVDR) 05/2022 und Programm für die BDDH-Veranstaltung im Rahmen des GTH-Kongresses 2022 in Leipzig." Hämostaseologie 41, no. 06 (2021): 506–8. http://dx.doi.org/10.1055/a-1370-0368.

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Ablösung der In-Vitro-Diagnostika-Richtlinie auf die In-Vitro-Diagnostika-Verordnung (IVDR) 05/2022 (Christoph Sucker, Günther Kappert) Planmäßig soll am 26.05.2022 die bisher geltende In-Vitro-Diagnostika-Richtlinie durch die In-Vitro-Diagnostika-Verordnung (IVDR) ersetzt werden und würde dann an diesem Tag unmittelbar rechtlich wirksam.

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Vermeersch, Pieter, Tobias Van Aelst, and Elisabeth M. C. Dequeker. "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." Clinical Chemistry and Laboratory Medicine (CCLM) 59, no. 1 (2021): 101–6. http://dx.doi.org/10.1515/cclm-2020-0804.

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AbstractObjectivesThe new European In Vitro Diagnostic (IVD) Regulation 2017/746 (IVDR) restricts the use of lab-developed tests (LDT) after 26th May 2022. There are no data on the impact of the IVDR on laboratories in the European Union.MethodsLaboratory tests performed in UZ Leuven were divided in four groups: core laboratory, immunology, special chemistry, and molecular microbiology testing. Each test was classified as Conformité Européenne (CE)-IVD, modified/off-label CE-IVD, commercial Research Use Only (RUO) or LDT. Each matrix was considered a separate test.ResultsWe found that 97.6% of

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De Decker, Steven, Anne-Sophie Warner, and Holger A. Volk. "Prevalence and breed predisposition for thoracolumbar intervertebral disc disease in cats." Journal of Feline Medicine and Surgery 19, no. 4 (2016): 419–23. http://dx.doi.org/10.1177/1098612x16630358.

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Objectives The objective was to evaluate the prevalence and possible breed predilections for thoracolumbar intervertebral disc disease (IVDD) in cats. Methods Medical records and imaging studies of cats diagnosed with thoracolumbar IVDD between January 2008 and August 2014 were retrospectively reviewed and compared with the general hospital population. The association between type of IVDD (ie, intervertebral disc extrusion [IVDE] or intervertebral disc protrusion [IVDP]) and breed, age, sex, and duration and severity of clinical signs was also evaluated. Results Of 12,900 cats presented during

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11

Tawfik, O., L. Peterson, R. Parker, et al. "Correlation between immunohistochemical biomarker expression and in vitro drug response factors in stage III-IV ovarian cancer." Journal of Clinical Oncology 25, no. 18_suppl (2007): 16055. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.16055.

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16055 Background: The reliability of molecular biomarkers as predictors of treatment outcome remains unclear and, in relation to drug resistance even less is known. Immunohistochemical (IHC) expression of biomarkers and in vitro drug resistance (IVDR) relative to clinical outcome were evaluated in patients with stage III-IV epithelial ovarian cancer (OC) who received combination carboplatin (CAR) plus paclitaxel (TAX) chemotherapy. Methods: We correlated clinical outcome with histopathology and biomarker expression of MIB-1, p53, BCL2, EGFR, ER and PR in 98 OC patients with tumors tested for I

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Kübra Ece, Hatice, and Jutta Dillschneider. "EU-Richtlinie: In-vitro-Diagnostika unter der IVDR." Klinik Einkauf 05, no. 01 (2023): 38–40. http://dx.doi.org/10.1055/s-0042-1764267.

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Auch wenn die Übergangsfristen für In-vitro-Diagnostika (IVD) verlängert wurden, bringt die IVDR neue Regelungen im Bereich der Lab Developed Tests mit sich, die der Krankenhauseinkauf beachten sollte.

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Streichert, Thomas. "Software als Medizinprodukt: Neue Anforderungen durch die IVDR." Trillium Diagnostik 20, no. 1 (2022): 15–17. http://dx.doi.org/10.47184/td.2022.01.02.

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14

Schnell-Inderst, Petra, and Claudia Wild. "PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment." International Journal of Technology Assessment in Health Care 35, S1 (2019): 43. http://dx.doi.org/10.1017/s026646231900196x.

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IntroductionIn Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence ge

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15

Balla, Ján. "Implementačné úskalia nového nariadenia EU/2017/746 In vitro diagnostické zdravotnícke pomôcky / Implementation challenges of the new EU/2017/746 In vitro diagnostic medical devices regulation." Laboratórna Diagnostika XXVII, no. 1/2022 (2022): 96–106. https://doi.org/10.5281/zenodo.6457967.

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<strong>Súhrn</strong> V roku 1998 prijala Európska únia smernicu EÚ (98/79/ES), ktorá reguluje diagnostické zdravotnícke pomôcky <em>in vitro</em>  (IVD). Pri interpretácii smernice sa v&scaron;ak objavili problémy, pretože poskytovala nízku úroveň kontroly a preskúmania u potenciálne &bdquo;vysoko rizikových“ diagnostických prípravkov. Nové IVD technológie si na ochranu a bezpečnosť pacientov vyžiadali jej reformu. Nové eur&oacut

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Weihs, Sayo, Gadison Quick, and Ivana Bogdanich. "1096. Evaluation of Vancomycin Pharmacokinetics in Intravenous Drug Users." Open Forum Infectious Diseases 8, Supplement_1 (2021): S639—S640. http://dx.doi.org/10.1093/ofid/ofab466.1290.

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Abstract Background People who inject illicit drugs (PWID) are 16 times more likely to develop methicillin-resistant Staphylococcus aureus (MRSA) infections including severe infections like bacteremia and endocarditis. Vancomycin is recommended as the drug of choice for empiric and targeted coverage in both severe and non-severe MRSA infections. Pharmacokinetic literature has suggested up to 31% higher renal clearance in intravenous drug users (IVDU) compared to non-IVDUs. This increased clearance may theoretically lead to more frequent sub-therapeutic troughs in otherwise standard dosing sche

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Becht, Christine, and Thomas Willaschek. "In-vitro-Diagnostika aus Eigenherstellung unter Geltung der IVDR." Medizinrecht 39, no. 9 (2021): 809–13. http://dx.doi.org/10.1007/s00350-021-5978-8.

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SAITOU, Atsushi, Fumio KUGIYA, and Naoki KODAMA. "Standardization ^|^amp; Application Expansion Activity of Removable HDD (iVDR)." IEICE Transactions on Electronics E96.C, no. 12 (2013): 1508–14. http://dx.doi.org/10.1587/transele.e96.c.1508.

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Spitzenberger, F. "Consequences of the EU IVDR implementation for medical laboratories." Klinická biochemie a metabolismus 32, no. 1 (2024): 4–6. https://doi.org/10.61568/kbm.2024.002.

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Oh, Jae-Young, Jun-Geon Je, Hyo-Geun Lee, et al. "Anti-Hypertensive Activity of Novel Peptides Identified from Olive Flounder (Paralichthys olivaceus) Surimi." Foods 9, no. 5 (2020): 647. http://dx.doi.org/10.3390/foods9050647.

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There is a growing interest in the health benefits of functional foods. A benefit that has been long sought is the control of hypertension through dietary approaches. Hypertension has been implicated as a risk factor for cardiovascular disease and is therefore of clinical significance. Here, we aim to demonstrate the antihypertensive activity of novel peptides derived from surimi, a functional food ingredient made from refined fish myofibrillar proteins. Three peptides, Ile-Val-Asp-Arg (IVDR), Trp-Tyr-Lys (WYK), and Val-Ala-Ser-Val-Ile (VASVI), were isolated from surimi made from the olive flo

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Shichrur, Rachel, and Navah Z. Ratzon. "Optimal Duration of In-Vehicle Data Recorder Monitoring to Assess Bus Driver Behavior." Sensors 23, no. 21 (2023): 8887. http://dx.doi.org/10.3390/s23218887.

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This study examined the optimal sampling durations for in-vehicle data recorder (IVDR) data analysis, focusing on professional bus drivers. Vision-based technology (VBT) from Mobileye Inc. is an emerging technology for monitoring driver behavior and enhancing safety in advanced driver assistance systems (ADASs) and autonomous driving. VBT detects hazardous driving events by assessing distances to vehicles. This naturalistic study of 77 male bus drivers aimed to determine the optimal duration for monitoring professional bus driving patterns and the stabilization point in risky driving events ov

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Bernát, Ivan. "Zmeny v zákone č.362/2011 Z.z. v súvislosti s implementáciou Nariadenia EP a R EÚ 2017/746 (IVDR) / Changes in Act No. 362/2011 Coll. in connection with the implementation of Regulation (EU) 2017/746 of the European Parliament and of the Council (IVDR)." Laboratórna Diagnostika XXVII, no. 2/2022 (2022): 34. https://doi.org/10.5281/zenodo.7319308.

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<strong>SÚHRN</strong> Prezentácia sa týka zmien v zákone č.362/2011 Z.z., ktoré sú dôsledkom  implementácie IVDR . Cieľom je zabezpečiť bezproblémové fungovanie vnútorného trhu s diagnostickými zdravotníckymi pomôckami in vitro, pričom sa dôraz kladie na vysokú úroveň ochrany zdravia pacientov a používateľov. Zároveň sa pre výrobcov stanovujú vysoké normy kvality a bezpečnosti diagnostických zdravotníckych po

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Vogeser, Michael. "IVDR and diagnostic application of mass spectrometry in the European Union." Journal of Mass Spectrometry and Advances in the Clinical Lab 19 (January 2021): 32–33. http://dx.doi.org/10.1016/j.jmsacl.2021.02.001.

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Kahveci, R., and P. Usakpinar. "PMD138 - IMPACTS OF NEW EU MDR&IVDR REGULATIONS FOR TURKEY." Value in Health 21 (October 2018): S266—S267. http://dx.doi.org/10.1016/j.jval.2018.09.1587.

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Verbeke, Hannelien, Donald Van Hecke, Caroline Bauraing, et al. "Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology." Applied Immunohistochemistry & Molecular Morphology 32, no. 1 (2023): 1–16. http://dx.doi.org/10.1097/pai.0000000000001165.

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Analytical verification and validation of immunohistochemical (IHC) tests and their equipment are common practices for today’s anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent authority regarding licensing of medical laboratories) performed in 2016, demonstrated a significant interlaboratory variation in validation procedures of IHC tests among Belgian laboratories. These results suggest the unavailability of practical information on the approach to the verification and validation

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Heinzelmann, Elsbeth. "The New, Stringent MDR and IVDR Regulations: Viewing this Change as an Opportunity." CHIMIA International Journal for Chemistry 72, no. 6 (2018): 430–31. http://dx.doi.org/10.2533/chimia.2018.430.

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ANITEI, Vlad-Alexandru, and Albert-Zsolt BARABAS. "Evaluation of the Effectiveness of Regulatory Compliance Training Programs for MDR and IVDR." Acta Marisiensis. Seria Technologica 21, no. 2 (2024): 15–19. https://doi.org/10.62838/amset-2024-0012.

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The NoBoCap training program for market operators has played a critical role in supporting the implementation of the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This initiative seeks to equip market operators with the essential knowledge and skills required to navigate the rigorous compliance requirements of these regulations. The present study aimed to assess the program’s effectiveness by focusing on three core objectives: (1) evaluating participant needs, (2) analyzing the efficacy of marketing strategies, and (3) measuring course outcomes. A

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Shaw, Collin, Dominik Vogt, Anna Melone, et al. "Analytical Validation and Stability Studies for Basophil Activation Test to Meet IVDR Certification." Journal of Allergy and Clinical Immunology 153, no. 2 (2024): AB30. http://dx.doi.org/10.1016/j.jaci.2023.11.116.

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Quigley, Muireann, Laura Downey, Zaina Mahmoud, and Jean McHale. "The Shape of Medical Devices Regulation in the United Kingdom? Brexit and Beyond." Law, Technology and Humans 5, no. 2 (2023): 21–42. http://dx.doi.org/10.5204/lthj.3102.

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The United Kingdom’s Medicines and Medical Devices Act (MMD Act) 2021 received royal assent on 11 February 2021. In its passage through parliament, as well as in the accompanying Explanatory Notes, the Act was framed by the government as a necessary post-Brexit bill. Yet prior to this, it was widely presumed that existing statutory instruments, enacted in 2019 to address medical devices regulation in anticipation of a ‘No Deal Brexit’, would provide the United Kingdom (UK) with the necessary legal framework through the transition period and beyond. The European Union (EU) exit legislation incl

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Lin, Yazhou, Guoqing Tang, Yucheng Jiao та ін. "Propionibacterium acnes Induces Intervertebral Disc Degeneration by Promoting iNOS/NO and COX-2/PGE2 Activation via the ROS-Dependent NF-κB Pathway". Oxidative Medicine and Cellular Longevity 2018 (19 серпня 2018): 1–12. http://dx.doi.org/10.1155/2018/3692752.

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Accumulating evidence suggests that Propionibacterium acnes (P. acnes) is a novel pathogenic factor promoting intervertebral disc degeneration (IVDD). However, the underlying mechanisms by which P. acnes induces IVDD have been unclear. In this study, we quantified the severity of IVDD, as well as the expressions of inducible nitric oxide synthase (iNOS)/nitric oxide (NO) and cyclooxygenase (COX-2)/prostaglandin (PGE2) in human intervertebral discs (IVDs) infected with P. acnes. Compared with P. acnes-negative IVDs, P. acnes-positive IVDs showed increased iNOS/NO and COX-2/PGE2 activity concomi

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31

Barberis, Massimo. "In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?" Pathologica 113, no. 2 (2021): 68–69. http://dx.doi.org/10.32074/1591-951x-237.

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Bossuyt, P. "What type of clinical evidence study designs are required in the new IVDR era?" Clinica Chimica Acta 493 (June 2019): S750. http://dx.doi.org/10.1016/j.cca.2019.03.1465.

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Leathers, A., C. Shaw, D. Vogt, et al. "Validation analytique et études de stabilité pour un test d’activation des basophiles commercial certifié IVDR." Revue Française d'Allergologie 65 (April 2025): 104263. https://doi.org/10.1016/j.reval.2025.104263.

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Dähn, O., J. Johnson, B. Ricken, L. Anchling, and C. B. Gerhold. "P0270 Standardisation of Rapid TDM Assay with WHO International Reference Material for Anti-Infliximab Antibodies." Journal of Crohn's and Colitis 19, Supplement_1 (2025): i704. https://doi.org/10.1093/ecco-jcc/jjae190.0444.

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Abstract Background Point-of-care (POC) tests play a crucial role in therapeutic drug monitoring (TDM) for Inflammatory bowel disease (IBD) patients undergoing anti-TNF therapy. Infliximab (IFX), the first biologic used in IBD treatment, is a chimeric anti-TNF-alpha blocker. However, its composition can trigger an immune response in patients, leading to the production of anti-drug antibodies (ADAs). Consequently, regular monitoring for ADAs is essential during IFX therapy. Various assays are available to measure anti-IFX antibody levels, mainly based on ELISA technology. The recent introductio

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Kupka, Johannes, Annika Kohler, Karima El Bagdadi, et al. "Adrenoceptor Expression during Intervertebral Disc Degeneration." International Journal of Molecular Sciences 21, no. 6 (2020): 2085. http://dx.doi.org/10.3390/ijms21062085.

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Healthy and degenerating intervertebral discs (IVDs) are innervated by sympathetic nerves, however, adrenoceptor (AR) expression and functionality have never been investigated systematically. Therefore, AR gene expression was analyzed in both tissue and isolated cells from degenerated human IVDs. Furthermore, human IVD samples and spine sections of wildtype mice (WT) and of a mouse line that develops spontaneous IVD degeneration (IVDD, in SM/J mice) were stained for ARs and extracellular matrix (ECM) components. In IVD homogenates and cells α1a-, α1b-, α2a-, α2b-, α2c-, β1-, and β2-AR genes we

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De Vos, N., M. Antoine, M. Bruyneel, A. Roman, and F. Cotton. "IVDR performance study of angiotensine-1-7, TGF-beta and KL-6 for COVID-19 sequela." Clinica Chimica Acta 558 (May 2024): 118028. http://dx.doi.org/10.1016/j.cca.2024.118028.

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Lasne, D., S. Testa, S. Kitchen, C. Gardiner, P. Meier, and F. Mullier. "Clinical laboratories need more information about commercially available reagents to prepare to IVDR: A call from ICSH." Hämostaseologie 45, S 01 (2025): S30. https://doi.org/10.1055/s-0044-1801587.

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Valla, Vasiliki, Saba Alzabin, Angeliki Koukoura, Amy Lewis, Anne Ahlmann Nielsen, and Efstathios Vassiliadis. "Companion Diagnostics: State of the Art and New Regulations." Biomarker Insights 16 (January 2021): 117727192110477. http://dx.doi.org/10.1177/11772719211047763.

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Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range

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Lubbers, Bart R., Isabel Dombrink, Tomas Kalina, et al. "Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities." HemaSphere 7, no. 4 (2023): e865. http://dx.doi.org/10.1097/hs9.0000000000000865.

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Bhatia, Sudhir, and Gudrun Baersch. "Determination of the shelf life of primers used in conventional polymerase chain reaction for pathogen detection." Atlantic Journal of Medical Science and Research 4, no. 3 (2024): 84. http://dx.doi.org/10.5455/atjmed.2024.08.013.

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Aim: Polymerase chain reaction (PCR) is an essential tool for the detection of many pathogens, relying on the use of primers. However, there is limited literature on the shelf life of these nucleotides, which is crucial for meeting the stability requirements of European regulations for in vitro diagnostic medical devices (IVDR) (Regulation (EU) 2017/746). This study aims to determine the shelf life of primers used in conventional PCR. Materials and Methods: Over the past 15 years, we have conducted numerous PCR experiments for various pathogens to estimate the shelf life of dissolved oligonucl

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Sahoo, Dr Chinmaya Keshari, Nidhi Shree, and Amiyakanta Mishra. "FORMULATION AND CHARACTERIZATION OF LIQUISOLID TABLETS FOR IMPROVING DISSOLUTION OF TELMISARTAN." Fabad Journal of Pharmaceutical Sciences 50, no. 1 (2025): 51–64. https://doi.org/10.55262/fabadeczacilik.1518230.

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The current study's objective was to create liquisolid tablets (LST) in order to improve the dissolution profile of telmisartan, a poorly soluble medication (BCS class II). To prepare LST, the following ingredients were used: microcrystalline cellulose (MCC) as the carrier, PEG as the vehicle, croscarmelose sodium (CCS) as the superdisintegrant, and Aerosil 200 as the coating material. The tablet quality control tests, flow characteristics, and interactions between the medication and excipient were assessed for each formulation. Higuchi, Korsmeyer-Peppas, zero order, and first order pharmacoki

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Mingay, Henry R. F., Rita Hendricusdottir, Aaron Ceross, and Jeroen H. M. Bergmann. "Using Rule-Based Decision Trees to Digitize Legislation." Prosthesis 4, no. 1 (2022): 113–24. http://dx.doi.org/10.3390/prosthesis4010012.

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This article introduces a novel approach to digitize legislation using rule based-decision trees (RBDTs). As regulation is one of the major barriers to innovation, novel methods for helping stakeholders better understand, and conform to, legislation are becoming increasingly important. Newly introduced medical device regulation has resulted in an increased complexity of regulatory strategy for manufacturers, and the pressure on notified body resources to support this process is making this an increasing concern in industry. This paper explores a real-world classification problem that arises fo

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Pradhan, Anuj K., Brian T. W. Lin, Claudia Wege, and Franziska Babel. "Effects of Behavior-Based Driver Feedback Systems on the Speeding Violations of Commercial Long-Haul Truck Drivers." Safety 10, no. 1 (2024): 24. http://dx.doi.org/10.3390/safety10010024.

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A third of large truck crashes are associated with driver-related factors, especially speeding. This study aimed to examine the impact of behavior-based safety (BBS) programs on speeding. Speeding data were examined from a trucking fleet that had incorporated a BBS program using in-vehicle data recorders (IVDR) and post hoc feedback. Speeding events were examined over 37 weeks in two stages—an initial 4-week period (Stage 1), and the final 30 weeks (Stage 2). In Stage 1, data were collected without any feedback. In Stage 2, a subset of the drivers received feedback. A cluster analysis was perf

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Михалко, Роман О. "СЕРТИФІКАЦІЙНІ СИСТЕМИ МЕНЕДЖМЕНТУ МЕДИЧНИХ ВИРОБІВ: ПОНЯТТЯ ТА ІНСТИТУЦІЙНЕ ЗАБЕЗПЕЧЕННЯ В УМОВАХ ЄВРОІНТЕГРАЦІЇ УКРАЇНИ". Journal of Strategic Economic Research, № 1 (8 липня 2025): 39–52. https://doi.org/10.30857/2786-5398.2025.1.3.

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Стаття присвячена дослідженню сутності та інституційному забезпеченню сертифікаційних систем менеджменту медичних виробів в Україні. Здійснено декомпозицію ключових понять категорії «сертифікаційна система менеджменту». Розкрито сутність дефініцій «система управління», «система управління якістю», «сертифікація», «Оцінка відповідності», «медичний виріб». Встановлено необхідність чіткого розмежування таких ключових понять як «сертифікація» та «оцінка відповідності», за якого обґрунтовано визнання сертифікації однією з форм ширшої категорії оцінки відповідності. На основі проведеного аналізу зап

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Mullier, François, Piet Meijer, Christa Cobbaert, and Dominique Lasne. "Attempts to align research in thrombosis and hemostasis with the In Vitro Diagnostic Medical Device Regulation (IVDR, European Union) requirements." Journal of Thrombosis and Haemostasis 23, no. 7 (2025): 2107–11. https://doi.org/10.1016/j.jtha.2025.04.001.

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Romano, M., M. Gerspach, and C. B. Gerhold. "Évaluation de la performance clinique d’un test d’activation de basophiles pour les troubles allergiques dans le cadre de la conformité IVDR." Revue Française d'Allergologie 65 (April 2025): 104269. https://doi.org/10.1016/j.reval.2025.104269.

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Kahles, Andy, Hannah Goldschmid, Anna-Lena Volckmar, et al. "Structure and content of the EU-IVDR." Die Pathologie, February 3, 2023. http://dx.doi.org/10.1007/s00292-022-01176-z.

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Abstract Background Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-certified IVDs (CE-IVDs), in-house IVDs (IH-IVDs), and r

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Auw-Hädrich, Claudia, Thomas Reinhard, and Johannes Haedrich. "Zur Umsetzung der Verordnung (EU) 2017/746 vom 5. April 2017 über In-vitro-Diagnostika (IVDR) in medizinischen Laboratorien, insbesondere in der Ophthalmopathologie." Klinische Monatsblätter für Augenheilkunde, May 30, 2022. http://dx.doi.org/10.1055/a-1863-9331.

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Die Europäische Kommission hat die Richtlinie 98/79/EG über In-vitro-Diagnostika (IVDD) überarbeitet, um die Sicherheit der Patienten zu verbessern und dem technischen Fortschritt angemessen Rechnung zu tragen. Mit der neuen Verordnung (EU) 2017/746 vom 25. Mai 2017 über In-vitro-Diagnostika (IVDR) gelten innerhalb der Europäischen Union hohe Standards für Qualität und Sicherheit von In-vitro-Diagnostika (IVD). Die IVDR richtet sich in erster Linie an Hersteller und Anbieter von IVD, hat aber auch erhebliche Auswirkungen auf medizinisch-diagnostische Labore. Ihre Anwendung ist seit dem 26. Mai

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Kahles, Andy, Hannah Goldschmid, Anna-Lena Volckmar, et al. "Die Verordnung (EU) 2017/746 (IVDR) in der Praxis: Umsetzung von Anhang I in der Pathologie. Englische Version." Die Pathologie, December 4, 2023. http://dx.doi.org/10.1007/s00292-023-01274-6.

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Abstract Background Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) imposes several conditions on pathology departments that develop and use in-house in vitro diagnostic medical devices (IH-IVDs). However, not all of these conditions need to be implemented immediately after the IVDR entered into force on 26 May 2022. Based on an amending regulation of the European Parliament and the Council of the European Union, the requirements for IH-IVDs will be phased in. Conformity with the essential safety and performance requirements of annex I must be ensured from May 2022. Obje

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Bank, Paul C. D., Leo H. J. Jacobs, Sjoerd A. A. van den Berg, 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." Clinical Chemistry and Laboratory Medicine (CCLM), November 23, 2020. http://dx.doi.org/10.1515/cclm-2020-1384.

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AbstractThe in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passag

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