ArticleJMIR medical informatics2024
Exploring Impediments Imposed by the Medical Device Regulation EU 2017/745 on Software as a Medical Device.
Article in JMIR medical informatics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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
14 citing papers in PubMed.
- Cold Plasma-Enabled Interface Engineering and In-Situ Functionalization of Printable Feedstocks in Additive Manufacturing: Mechanisms, Materials, and Applications.Pharmaceutics · 2026Review
- A comprehensive survey of AI agents in healthcare.Journal of biomedical informatics · 2026Review
- Impact of the new European medical device regulation on digital health manufacturers.NPJ digital medicine · 2026Article
- Organizational Tensions in the Implementation of Modifiable Off-the-Shelf Technologies in a University Hospital: Qualitative Multimethod Study.JMIR human factors · 2026Article
- Safety Envelopes and Continuous Assurance for Updates and Postmarket Surveillance in Digital Mental Health Technologies.Journal of medical systems · 2026Article
- Artificial intelligence in the early diagnosis of prostate cancer: from multimodal imaging to liquid biopsy.Frontiers in oncology · 2026Review
- From Innovation to Integration: Bridging the Gap Between IoMT Technologies and Real-World Health Management Systems.Sensors (Basel, Switzerland) · 2025Article
- Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study.Journal of medical Internet research · 2025Article
- Unlocking the Potential of mHealth: Integrating Behaviour Change Techniques in Hypertension App Design.International journal of environmental research and public health · 2025Article
- Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- The Limitations of Artificial Intelligence in Head and Neck Oncology.Advances in therapy · 2025Review
- A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study.Journal of medical Internet research · 2025Article
- A decade of review in global regulation and research of artificial intelligence medical devices (2015-2025).Frontiers in medicine · 2025Review
- Deficiencies of the EU Medical Device Regulation when applying its own rules.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In light of rapid technological advancements, the health care sector is undergoing significant transformation with the continuous emergence of novel digital solutions. Consequently, regulatory frameworks must continuously adapt to ensure their main goal to protect patients. In 2017, the new Medical Device Regulation (EU) 2017/745 (MDR) came into force, bringing more complex requirements for development, launch, and postmarket surveillance. However, the updated regulation considerably impacts the manufacturers, especially small- and medium-sized enterprises, and consequently, the accessibility of medical devices in the European Union market, as many manufacturers decide to either discontinue their products, postpone the launch of new innovative solutions, or leave the European Union market in favor of other regions such as the United States. This could lead to reduced health care quality and slower industry innovation efforts. Effective policy calibration and collaborative efforts are essential to mitigate these effects and promote ongoing advancements in health care technologies in the European Union market. This paper is a narrative review with the objective of exploring hindering factors to software as a medical device development, launch, and marketing brought by the new regulation. It exclusively focuses on the factors that engender obstacles. Related regulations, directives, and proposals were discussed for comparison and further analysis.
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.