Evidence map›Paper›PMID 38515785›Full record

ArticleGerman medical science : GMS e-journal2024

Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung - Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023.

Michael Vogeser, Monika Brüggemann, Kristina Brandt, Uta Ceglarek, Volker Gieskes, Niclas Hitziger, Andy Kahles, Ernst Klar, Dirk Roggenbuck, Henning Schliephake and 6 more

Abstract read
In one paragraph

Article in German medical science : GMS e-journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Michael VogeserInstitut für Laboratoriumsmedizin, Klinikum der Universität München, LMU München, Deutschland.
Monika BrüggemannKlinik für Innere Medizin II, Sektion für Hämatologische Spezialdiagnostik, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Deutschland.
Kristina BrandtZentrum für Klinische Studien, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Deutschland.
Uta CeglarekInstitut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik, Universitätsklinikum Leipzig, Deutschland.
Volker GieskesMinisterium für Soziales, Gesundheit, Integration und Verbraucherschutz, Land Brandenburg, Potsdam, Deutschland.
Niclas HitzigerRoche Diagnostics, Rotkreuz, Schweiz.
Andy KahlesInstitut für Pathologie, Universitätsklinikum Heidelberg, Deutschland.
Ernst KlarAWMF Ad-hoc-Kommission Bewertung von Medizinprodukten, Berlin, Deutschland.
Dirk RoggenbuckMedipan GmbH, Blankenfelde-Mahlow, Deutschland.
Henning SchliephakeKlinik für Mund-, Kiefer- und Gesichtschirurgie, Georg-August-Universität Göttingen, Deutschland.
Ortwin SchulteBundesministerium für Gesundheit, Bonn, Deutschland.
Sascha WettmarshausenVerband der Diagnostica-Industrie (VDGH e.V.), Berlin, Deutschland.
Uwe ZimmermannDeutsche Akkreditierungsstelle (DAkkS), Frankfurt, Deutschland.
Ulrich SackInstitut für Klinische Immunologie, Universitätsklinikum Leipzig, Deutschland.
Albrecht StenzingerInstitut für Pathologie, Universitätsklinikum Heidelberg, Deutschland.
Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V. (AWMF)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

MedicineHumansSocieties, MedicalIVDR

Identifiers

PMID38515785
PMCPMC10952015

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.