In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.
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http://dx.doi.org/10.3205/000327 | DOI Listing |
Ger Med Sci
March 2024
Institut für Pathologie, Universitätsklinikum Heidelberg, Deutschland.
In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar.
View Article and Find Full Text PDFBundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
January 2023
CML Advocates Network, Patvocates, München, Deutschland.
The currently valid Regulation (EU) 536/2014 on clinical trials with medicinal products for human use brings some innovations that are of great importance for patients who participate in clinical trials and patients with a need for innovative therapies. These concern patient protection, especially for vulnerable patient groups, as well as the conditions for further use of data obtained in clinical trials. The introduction of the largely publicly available information system CTIS (Clinical Trials Information System) will significantly improve the transparency of ongoing clinical trials.
View Article and Find Full Text PDFBundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
January 2023
Paul-Ehrlich-Institut (PEI), Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Str. 51-59, 63225, Langen, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
January 2023
QUEST Center for Responsible Research, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Anna-Louisa-Karsch-Str. 2, 10178, Berlin, Deutschland.
Clinical studies can be more or less transparent in four areas: (a) study registration, (b) results reporting, (c) data/code sharing, and (d) study-related documents. This discussion paper explains the extent to which the EU Regulation 536/2014 (Clinical Trials Regulation - CTR) has already positively impacted the area of results reporting in interventional drug trials and how it can improve the availability of study-related documents for independent research in the future.As this positive trend exists only for the area of results reporting and for the subset of interventional drug trials addressed by the CTR so far, a problematic two-class transparency seems to be developing that distinguishes between clinical studies addressed by the CTR and the other clinical studies.
View Article and Find Full Text PDFBundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
January 2023
Ethikkommission der Medizinischen Fakultät der Universität zu Köln, Kerpener Str. 62, 50937, Köln, Deutschland.
After Regulation (EU) No. 536/2014 (Clinical Trial Regulation, CTR) of the European Parliament and of the Council took effect on 31 January 2022, the application process for clinical trials fundamentally changed. This article describes the fundamental procedural changes and the resulting changes for Germany and, in particular, for the ethics committees.
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