ArticleBMJ (Clinical research ed.)2016
Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.
Article in BMJ (Clinical research ed.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Outcomes Associated With Intracranial Aneurysm Treatments Reported as Safe, Effective, or Durable: A Systematic Review and Meta-Analysis.JAMA network open · 2023Pooled it
- Trial
- Robot-Assisted Mechanical Thrombectomy for Neurointerventional Surgery: An Exploratory Scoping Review.Journal of robotic surgery · 2026Article
- Mapping the evidence supporting FDA-authorized digital therapeutics, before and after authorization.NPJ digital medicine · 2026Article
- Evaluating the impact of the EU Medical Device Regulation (MDR) on mortality and device availability in Germany.PloS one · 2026Article
- From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies.Diagnostics (Basel, Switzerland) · 2025Review
- Mind the (research) gap: a retrospective observational study on the utilization of new medical technologies and related research activities in German hospitals.Health research policy and systems · 2025Observational
- Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries.Circulation. Cardiovascular quality and outcomes · 2025Article
- Scoping review on regulation, implementation and postmarket surveillance of medical devices.PloS one · 2025Article
- Orphan medical devices: addressing the regulatory and access gaps in the EU and US.Frontiers in public health · 2025Article
- Leveraging natural language processing to aggregate field safety notices of medical devices across the EU.NPJ digital medicine · 2024Article
- Market of First Launch for High-Risk Therapeutic Medical Devices.JAMA network open · 2024Article
- Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device.JMIR medical informatics · 2024Article
- Postmarket Surveillance of Neuroendovascular Devices.Stroke (Hoboken, N.J.) · 2024Review
- The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study.Therapeutic innovation & regulatory science · 2023Article
- Orphan Medical Devices and Pediatric Cardiology - What Interventionists in Europe Need to Know, and What Needs to be Done.Pediatric cardiology · 2023Review
- Introducing Machine Perfusion into Routine Clinical Practice for Liver Transplantation in the United States: The Moment Has Finally Come.Journal of clinical medicine · 2023Review
- Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).European heart journal. Quality of care & clinical outcomes · 2022Article
- Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).EFORT open reviews · 2021Review
- Immunologic reactions to bone and articular implants.International orthopaedics · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union.
designCohort study.
settingNovel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010. DATA SOURCES: Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug Administration and European regulatory authority databases for US approvals and safety alerts and recalls; and Medline, Embase, and Web of Science for peer reviewed publications.
main outcome measuresWe categorized the novelty of the devices in the study sample as a "major innovation" or an "other change," and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential EU and US approvals. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the EU and devices approved only in the EU.
results67% (206/309) of devices identified were approved in both the US and the EU, of which 63% (129/206) were approved first in the EU. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% five years after approval.
conclusionsDevices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls. Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment.
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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.