Evidence map›Paper›PMID 39559338›Full record

ReviewGerman medical science : GMS e-journal2024

Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.

Andy Kahles, Hannah Goldschmid, Anna-Lena Volckmar, Daniel Kazdal, Ulrich M Gassner, Michael Vogeser, Monika Brüggemann, Karl-Friedrich Bürrig, Vanessa Kääb-Sanyal, Christa Flechtenmacher and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review 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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

12 authors.

Andy KahlesInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Hannah GoldschmidInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Anna-Lena VolckmarInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Daniel KazdalInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Ulrich M GassnerFaculty of Law, Augsburg University, Augsburg, Germany.
Michael VogeserInstitute of Laboratory Medicine, LMU University Hospital, LMU Munich, Germany.
Monika BrüggemannClinic for Internal Medicine II, Section for Special Hematology Diagnostics, University Hospital Schleswig-Holstein, Kiel, Germany.
Karl-Friedrich BürrigProfessional Association of German Pathologists, registered association, Berlin, Germany.
Vanessa Kääb-SanyalProfessional Association of German Pathologists, registered association, Berlin, Germany.
Christa FlechtenmacherInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Peter SchirmacherInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Albrecht StenzingerInstitute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation on medical devices (Regulation (EU) 2017/745, MDR) and the EU regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746, IVDR) resulted in a need for regulatory adjustments to German medical device law. This has created a new legal framework in which institutes for pathology operate, depending on their function as users, operators or in-house manufacturers of in vitro diagnostic medical devices. This overview of the current legal situation represents a snapshot and provides an up-to-date overview of the landscape of European and German medical device law.

Indexed as

Medical Device LegislationDevice ApprovalDiagnostic EquipmentEquipment and SuppliesEuropeEuropean UnionGermanyHumansin vitro diagnostic medical devices (IVD)IVDRlaws and regulationslegislationquality managementregulatory requirements

Identifiers

PMID39559338
PMCPMC11570832

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.