ReviewDrug safety2020
Medical Devices: Definition, Classification, and Regulatory Implications.
Review in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 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
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Digital Devices for Assessing Motor Functions in Mobility-Impaired and Healthy Populations: Systematic Literature Review.Journal of medical Internet research · 2022Pooled it
- Trial
- Safety, Technical and Clinical Success of the Aperio Hybrid Thrombectomy Device in Acute Ischemic Stroke, a Prospective Post-market Clinical Follow-up Study (HYBRID).Clinical neuroradiology · 2026Article
- A data-driven priority assessment and deployment framework for medical equipment maintenance in a tertiary hospital.Frontiers in artificial intelligence · 2026Article
- Medical devices in Europe, all but drugs: time to radically change their regulation?Internal and emergency medicine · 2026Article
- Advancing Regulatory Oversight of Medical Device Trials to Align with Clinical Drug Standards in the European Union.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Conducting Polymers-Based Gas Sensors: Principles, Materials, and Applications.Sensors (Basel, Switzerland) · 2025Review
- Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation.Bioengineering & translational medicine · 2025Review
- Importance to understand medical device regulations for accelerating clinical translation.Journal of orthopaedic translation · 2025Review
- Will the increase of medical equipment affect medical expenditure? Empirical evidence from a quasi-experiment in China.BMC health services research · 2025Article
- Improving precision instrument cleaning with a quality control module: implementation and outcomes.Frontiers in public health · 2025Article
- Prevalence of skin injuries related to medical adhesives in Brazilian hospitals: a multicenter study.Revista brasileira de enfermagem · 2025Article
- Engineering of Bioresorbable Polymers for Tissue Engineering and Drug Delivery Applications.Advanced healthcare materials · 2024Review
- Nanotechnology in healthcare, and its safety and environmental risks.Journal of nanobiotechnology · 2024Review
- Healthcare Experts' Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea: Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates.Journal of Korean medical science · 2024Review
- A Comprehensive Analysis of Class I Medical Device Recalls: Unveiling Patterns, Causes and Global Impacts.Cureus · 2024Article
- Design of osteosynthesis plate for detecting bone union using wire natural frequency.Scientific reports · 2024Article
- Perspectives: Delving into the experience of a nurse inventor.Journal of research in nursing : JRN · 2024Article
- Smart hospital: achieving interoperability and raw data collection from medical devices in clinical routine.Frontiers in digital health · 2024Article
- Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas.Journal of personalized medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional." Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.
Indexed as
Identifiers
31845212What 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.