ReviewEFORT open reviews2021
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).
Review in EFORT open reviews, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses 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
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Availability of Evidence for Predictive Machine Learning Algorithms in Primary Care: A Systematic Review.JAMA network open · 2024Pooled it
- Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.International journal of health policy and management · 2023Pooled it
- Clinical significance of field safety notices concerning implantable pacemakers and defibrillators.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Article
- Analysis of the challenges in ensuring robust and effective clinical evaluation of AI-based digital medical devices.BMJ digital health & AI · 2026Review
- Global market and supply chain implications of the European Union medical device regulation 2017/745 as amended by 2023/607.BMC health services research · 2025Article
- Cumulative risk of revision after primary total hip arthroplasty in registries internationally: systematic review and meta-analysis of selected hip stems and cups.EFORT open reviews · 2025Article
- Accuracy of online symptom assessment applications, large language models, and laypeople for self-triage decisions.NPJ digital medicine · 2025Article
- Leveraging natural language processing to aggregate field safety notices of medical devices across the EU.NPJ digital medicine · 2024Article
- Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.EFORT open reviews · 2023Article
- National spine surgery registries' characteristics and aims: globally accepted standards have yet to be met. Results of a scoping review and a complementary survey.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2023Article
- International Market Access Strategies for Artificial Intelligence-Based Medical Devices: Can We Standardize the Process to Faster Patient Access?Mayo Clinic proceedings. Digital health · 2023Article
- Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.Orphanet journal of rare diseases · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent 'conformity assessment' organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details - which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article:
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What OpenQuestion holds
Registered trials
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.