ReviewPharmacoepidemiology and drug safety2019
EU postmarket surveillance plans for medical devices.
Review in Pharmacoepidemiology and drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- Lip Augmentation With Saypha LIPS Lidocaine: A Postmarket, Prospective, Open-Label, Randomized Clinical Study To Evaluate Its Efficacy and Short- and Long-term Safety.Aesthetic surgery journal · 2024Trial
- Reported device problems and patient outcomes in da Vinci robotic robotic gastric and upper-gastrointestinal procedures: an FDA MAUDE database analysis.Journal of robotic surgery · 2026Article
- The Impact of Interfering Substances on Continuous Glucose Monitors: Part 4: Continuous Glucose Monitoring Interferents: In Vivo Performance, Clinical Implications and Future Standardization.Journal of diabetes science and technology · 2026Review
- Efficacy and safety of e.p.t.q. hyaluronic acid fillers in the context of aesthetic facial rejuvenation or beautification: a post-market clinical follow-up study.Scientific reports · 2026Article
- Patient Safety in Healthcare: A Proposal for Ensuring the Use of Regulation-Compliant Safety Devices.Therapeutic innovation & regulatory science · 2026Article
- Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data.The Indian journal of medical research · 2025Article
- Leveraging natural language processing to aggregate field safety notices of medical devices across the EU.NPJ digital medicine · 2024Article
- Limitations of NHIC claim code-based surveillance and the necessity of UDI implementation in Korea.Scientific reports · 2024Article
- Applications of Blockchain-Based Technology for Healthcare Devices Post-market Surveillance.Cureus · 2024Article
- Postmarket Surveillance of Neuroendovascular Devices.Stroke (Hoboken, N.J.) · 2024Review
- Analysis of reported adverse events of pipeline stents for intracranial aneurysms using the FDA MAUDE database.Journal of cerebrovascular and endovascular neurosurgery · 2023Article
- Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?Mayo Clinic proceedings. Digital health · 2023Review
- Quality analysis of manufacturer's incident reports regarding medical devices.Journal of pharmaceutical policy and practice · 2023Article
- Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes.Journal of diabetes science and technology · 2023Article
- Post-Market Surveillance Assessment of the Clinical Accuracy of a Blood Glucose Monitoring System with an Improved Algorithm for Enhanced Product Performance.Journal of diabetes science and technology · 2023Article
- Balancing the customization and standardization: exploration and layout surrounding the regulation of the growing field of 3D-printed medical devices in China.Bio-design and manufacturing · 2022Review
- Digital Contact Tracing Against COVID-19 in Europe: Current Features and Ongoing Developments.Frontiers in digital health · 2021Article
- Challenges Associated with the Safety Signal Detection Process for Medical Devices.Medical devices (Auckland, N.Z.) · 2021Review
- Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products.Materials (Basel, Switzerland) · 2020Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRecent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan.
methodsThis publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
resultsThe results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device.
conclusionsThe PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
Indexed as
Identifiers
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.