ReviewPediatric cardiology2023
Orphan Medical Devices and Pediatric Cardiology - What Interventionists in Europe Need to Know, and What Needs to be Done.
Review in Pediatric cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed, 25 citations in OpenAlex.
- Empowering regulatory science for medical devices in Europe.The Lancet regional health. Europe · 2026Review
- Medical device development and innovation for rare and pediatric populations: a global landscape overview.Orphanet journal of rare diseases · 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
- Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law.Frontiers in medical technology · 2025Review
- Minimal Access in Pediatric Surgery: An Overview on Progress towards Dedicated Instrument Developments and Anesthesiologic Advances to Enhance Safe Completion of Procedures.Children (Basel, Switzerland) · 2024Article
- Impact of new legislation on theJPGN reports · 2024Article
- Evidence from clinical trials on high-risk medical devices in children: a scoping review.Pediatric research · 2024Article
- The Medical Device Regulation and its impact on device development and research in Germany.Zeitschrift fur medizinische Physik · 2023Article
- Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.Orphanet journal of rare diseases · 2023Review
- Digital therapeutics from bench to bedside.NPJ digital 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
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Medical devices include a great diversity of technologies, which are evaluated and approved in the European Union (EU) according to a revised law that came into effect on 26 May 2021, known as the Medical Device Regulation or MDR (EU 745/2017). It has a transition period that allows products that were approved under the previous rules (the EU Medical Device Directives) to continue to be marketed until 26 May 2024 at the latest. As a result of a series of unforeseen factors, there is a possibility that the MDR may result in products becoming unavailable, with the consequent risk of a loss of some interventions that are reliant upon those devices. Devices that are used for orphan or pediatric indications are particularly vulnerable to this. There is an urgent need for policy to be developed to protect essential medical devices for orphan indications and for use in children, to ensure that necessary interventions can continue, and to ensure a more sustainable system in Europe over the longer term. Pediatric cardiologists in Europe need to be aware that particular medical devices may become unavailable over the next two years, and they should contribute to plans to mitigate this risk, so that they can continue to deliver the best possible care for their patients. This commentary examines the factors which have contributed to this issue and suggests ways that policy can be developed to address it.
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.