--- title: "Limits of Regulation: The Misleading Conflation of Safety and Benefit in Medical Devices" language: "en" type: "post" original_url: "https://www.atlas-digitale-gesundheitswirtschaft.de/en/blog/2025/07/08/limits-of-regulation-the-misleading-conflation-of-safety-and-benefit-in-medical-devices/" human_version: "../../../../../../mensch/en/blog/2025/07/08/limits-of-regulation-the-misleading-conflation-of-safety-and-benefit-in-medical-devices/" date: "2025-07-08" section: "Global Science Digest" categories: ["Medical Devices"] author: "Carolin Berlich [L. Flüß]" description: "The MDR was introduced for safety and innovation in medical technology. But can regulation provide evidence of clinical effectiveness?" publisher: "Lehrstuhl für Management und Innovation im Gesundheitswesen, Universität Witten/Herdecke" --- # Limits of Regulation: The Misleading Conflation of Safety and Benefit in Medical Devices *July 8, 2025 · Global Science Digest · By Carolin Berlich [L. Flüß]* *The European Medical Device Regulation (MDR) was introduced to strengthen safety and innovation in medical technology. But can regulatory approval be taken as evidence of clinical effectiveness?* Medical devices play a central role in addressing the growing strain on healthcare systems by limited resources and rising costs – primarily through the advancement of new technologies [1]. Spanning from simple adhesive bandages to complex implants and diagnostic systems, the medical device sector currently includes over 500,000 products on the market [2]. In the regulatory landscape, two key concepts dominate discussions: **safety** and **performance** (or effectiveness). While these are often seen as closely linked in practice, regulatory frameworks treat them as distinct domains. ### **43% of U.S. physicians conflate regulatory approval with therapeutic superiority** In [2024, Dhruva et al.](https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2023.00466) reported the results from a national survey of 509 U.S. internists, cardiologists, and oncologists, assessing their knowledge and perceptions of the FDA’s regulatory pathways for medical devices [3]. Only 17% of respondents reported understanding the approval process at least moderately well. 43% believed that a newly approved medical device was automatically more effective than existing alternatives. This assumption reflects a widespread belief that device approvals are based on high-quality clinical evidence. In reality, many devices are approved without reaching such thresholds, as moderate-risk devices are commonly cleared via the FDA 510(k) pathway and usually without having to present clinical trial data [3]. Moreover, 89% of the surveyed physicians believed that the FDA should withdraw approval from breakthrough-designated devices if they fail to demonstrate clinical benefit in post-market studies [3]. These findings suggest a significant gap between regulatory realities and physicians’ expectations. Physicians tend to overestimate the rigor of the approval process and wrongly equate regulatory clearance with therapeutic advancement. ### **The Medical Device Regulation`s impact on innovation and market attractiveness in Europe** The findings of Dhruva et al. are equally relevant in the European context. Under the MDR, product performance, including comparative effectiveness relative to existing products, is not a requirement for market approval [4]. But how clearly is this distinction understood by stakeholders? Surveys in Europe reveal a growing sense of around the MDR: A study from Finland by Huusko et al. (2023) illustrates that MDR information remains fragmented and often inaccessible, especially for small and medium sized enterprises (SMEs). Respondents reported difficulties navigating EU digital systems and emphasized the need for clearer, more practical guidance [5]. These challenges apply equally to manufacturers of physical and software-based products [5]. Increasing regulatory complexity has resulted in longer certification timelines and higher compliance costs, making the European Union less attractive as a market for medical innovation [6,7]. In Germany, these developments have caused over half of the manufactures to discontinue entire product lines —particularly for niche devices—and to relocate R&D activities outside the EU [8,9]. Figure 1: The discrepancy between regulatory approval and clinical performance ### **Regulation without relevance?** Taken together, these findings point to a broader pan-European pattern of regulatory uncertainty that affects both manufacturers and healthcare providers, fuels misinterpretations, and ultimately hampers innovation. MDR approval confirms conformity with regulatory standards, but it does not imply clinical superiority. Market presence or withdrawal may be driven just as much by economic factors as by clinical evidence. Understanding this distinction is crucial for physicians in order to provide accurate counselling to their patients and ensure high quality care. The perceptions that the MDR conveys to patients, healthcare professionals, and other stakeholders warrant systematic scientific investigation. Regulatory frameworks can only achieve their intended goal if their full impact is understood across all stakeholder groups. Given their pivotal role between manufacturers and patients, physicians’ perspectives should be systematically included in both the implementation and evaluation of regulatory frameworks. Last but not least, medical education should include basic knowledge about device regulation, enabling physicians to offer informed guidance to their patients. **Literatur** [1] I. Lee et al. (2006). High-confidence medical device software and systems, Computer, vol. 39, no. 4, pp. 33-38, doi: 10.1109/MC.2006.127. [2] Bundesverband Medizintechnologie e.V. (BVMed). Digitale Medizintechnik im Gesundheitssystem 2035: Datengetriebener Versorgungskosmos. Berlin: BVMed; 2023 [cited 2025 Apr 7]. Available from: [https://www.bvmed.de/download/digitale-medizintechnik-im-gesundheitssystem-2035-datengetriebener-versorgungskosmos](https://www.bvmed.de/download/digitale-medizintechnik-im-gesundheitssystem-2035-datengetriebener-versorgungskosmos) [3] Zhang AD, Dhruva SS, Anderson TS, Shah ND, Ross JS. Physicians’ perspectives on FDA regulation of drugs and medical devices: a national survey. Health Aff (Millwood). 2024 Jan;43(1):39–47. doi:10.1377/hlthaff.2023.00466 [4] European Parliament and Council of the European Union. *Regulation (EU) 2017/745*. Off J Eur Union. 2017 May 5; L117:1–175. [5] Huusko J, Kinnunen U-M, Saranto K. Medical device regulation (MDR) in health technology enterprises – perspectives of managers and regulatory professionals. *BMC Health Serv Res*. 2023;23(1):310. doi:10.1186/s12913-023-09316-8 [6] Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Huber TS, Regnault V, Badimon L, et al. Orphan medical devices and pediatric cardiology—what interventionists in Europe need to know, and what needs to be done. *Pediatr Cardiol*. 2023;44(2):271–279. doi:10.1007/s00246-022-03029-1 [7] [7] MedTech Europe. *MedTech Europe IVDR & MDR Survey Results 2024 – Report Highlights*. Brussels: MedTech Europe; 2025. [8] DIHK, MedicalMountains GmbH, SPECTARIS. *Current assessment of the German medical device manufacturers on the effects of the EU Medical Device Regulation (MDR)*. Berlin; 2023. Available from: [https://www.spectaris.de](https://www.spectaris.de), downloaded on 07.04.202 [9] Kearney B, McDermott O. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study. *Therapeutic Innovation & Regulatory Science (2023) 57:783–796, https.doi.org/10.1007/s43441-023-00527-z* #### Related Articles - [Robots as Co-Surgeons in the Operating Room](../../03/18/robots-as-co-surgeons-in-the-operating-room.md) - [Telehealth in care increases the flexibility of facilities in North Rhine-Westphalia](../../05/13/telehealth-in-care-increases-the-flexibility-of-facilities-in-north-rhine-westphalia.md) - [Resuscitation Documentation: Mobility and Efficiency through Tablet-Based Solutions](../../02/12/resuscitation-documentation-mobility-and-efficiency-through-tablet-based-solutions-2.md) **Categories:** Medical Devices ## Images on this page - Grafik-leicht-angepasst.2-e1751982129133.png: ../../../../../../mensch/assets/bilder/wp-content/uploads/2025/07/Grafik-leicht-angepasst.2-e1751982129133.png - shutterstock_561968221-min-scaled.jpg: ../../../../../../mensch/assets/bilder/wp-content/uploads/2023/11/shutterstock_561968221-min-scaled.jpg --- This page is optimised for AI systems. 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