ArticleTherapeutic innovation & regulatory science2023
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study.
Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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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.
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Who cites it
22 citing papers in PubMed.
- Empowering regulatory science for medical devices in Europe.The Lancet regional health. Europe · 2026Review
- Narrative over numbers: How testimonial medicine erodes safe practice.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2026Article
- 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
- Clinical Performance of REAC-Based ACT, CO, and MO-IBZ Protocols in Routine Practice: A Prospective Real-World Observational PMCF Study.Journal of clinical medicine · 2026Article
- The Italian landscape of digital therapeutics in a European context.Frontiers in digital health · 2026Review
- Technological innovation in healthcare: challenges, opportunities and impact on sustainability.Frontiers in digital health · 2026Review
- Early and accelerated access programs for medical devices in the European Union: mapping regulatory derogations and national schemes.Frontiers in medical technology · 2026Review
- A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study.Medical devices (Auckland, N.Z.) · 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
- Multiscale Design of Dental Restorative Materials: Mechanistic Foundations, Technological Innovations, and Clinical Translation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Review
- The Challenges of Vascular Implants: Regulatory Strategies and Biological Responses.Small science · 2025Review
- "Appropriateness" of Clinical Data Under Regulation (EU) 2017/745- A Case Study and Survey.Therapeutic innovation & regulatory science · 2025Article
- The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey.Therapeutic innovation & regulatory science · 2025Article
- Developing a Classification of Spinal Medical Devices: Has the Time Come? Review of the Literature and a Proposal for Spine Registries.Bioengineering (Basel, Switzerland) · 2025Article
- A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study.Journal of medical Internet research · 2025Article
- Virtual reality-enhanced rehabilitation for improving musculoskeletal function and recovery after trauma.Journal of orthopaedic surgery and research · 2025Review
- Article
- Deficiencies of the EU Medical Device Regulation when applying its own rules.Frontiers in medicine · 2025Article
- Scoping review on regulation, implementation and postmarket surveillance of medical devices.PloS one · 2025Article
- How to advance from minimally invasive coronary artery bypass grafting to totally endoscopic coronary bypass grafting: challenges in Europe versus United States of America.Annals of cardiothoracic surgery · 2024Review
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles. The findings from the study demonstrated that the highest source of reactive Post-Market Surveillance data was customer complaints and proactive data were Post-Market Clinical Follow-Up. In contrast, the top 3 sources for generating clinical evaluation data for legacy devices under the new Medical Device Regulations were Post-Market Surveillance data, Scientific literature reviews, and Post-Market Clinical Follow-Up studies. Manufacturers' biggest challenge under the new Medical Device Regulations is determining the amount of data needed to generate sufficient clinical evidence, while over 60% of high-risk device manufacturers have outsourced the writing of their clinical evaluation reports. Manufacturers also reported a high investment in clinical evaluation training and highlighted inconsistencies in the requirements for clinical data by different notified bodies. These challenges may lead to a potential shortage of certain medical devices in the E.U. and a delay in access to new devices, negatively impacting patient quality of life (1). This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the E.U.
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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.