Europe Rewrites the Rules for Approving Medical Devices

Europe is once again overhauling the way medical devices are approved, and the stakes could hardly be higher. From pacemakers and hip implants to genetic diagnostic tests, the regulatory framework that decides which technologies reach patients is being redrawn in Brussels. A new draft regulation tabled by the European Commission in December 2025 is now working its way through the European Parliament and Council, driven by political demands for simplification and competitiveness, but also by years of accumulated evidence that the current system produces inconsistent, and sometimes dangerously thin, clinical evidence. Writing in The Lancet Regional Health – Europe, a group of clinicians and regulatory scientists led by Alan G. Fraser of the European Society of Cardiology argues that the reform will fail unless it is anchored in genuine regulatory science, with far stronger scientific capacity inside the European Commission and its agencies.

The origins of device regulation in Europe are unusual, and arguably the root of many current problems. In the United States, legislation controlling pharmaceutical safety followed deaths from sulfanilamide syrup in 1937, and the first European Economic Community directive on medicines was a direct response to the thalidomide disaster of 1957 to 1962. American device legislation likewise grew out of a 1970 expert report chaired by Theodore Cooper, which attacked an unquestioning acceptance of safety claims unsupported by scientific fact. Europe’s device rules, by contrast, were not precipitated by any scandal and were not designed after objective analysis. They emerged from requests to the European Commission by manufacturers’ trade associations, and when the first Medical Device Directive was drafted in the late 1980s, policymakers applied the so-called New Approach adopted by the Council of Ministers in 1985, a framework intended to harmonise standards for industrial products across the common market, not to safeguard patients.

Under that New Approach, the evaluation of evidence demonstrating that a device conformed with requirements was outsourced to independent, private inspection companies known as notified bodies. Those organisations remain central to the system today: manufacturers must submit technical documentation, quality management systems and clinical evaluation reports to a notified body for all medium-risk Class II and high-risk Class III devices, and for nearly all in vitro diagnostics, before receiving the certificates of conformity required for CE-marking and market access. With hindsight, the authors argue, applying an industrial harmonisation model to high-risk medical devices was a poor decision. Notified bodies effectively act as quasi-regulators, deciding whether devices are approved, yet as private companies operating in a competitive marketplace they are not bound by European requirements for public access to documents. Their dual role also limits the advice they can give to the very companies whose products they assess, because of inherent conflicts of interest, and oversight by national authorities has often been inadequate.

The original directive’s rules were deliberately written in rather abstract terms, leaving manufacturers to decide for themselves what clinical studies were needed. Concerns accumulated over decades: standards varied between notified bodies, some devices reached patients with insufficient evidence, and serious complications and deaths were reported from high-risk implantables approved on claims of equivalence to existing devices without any new clinical investigation. A public consultation launched by the Commission in 2008 eventually produced the Medical Device Regulation, which came into force in 2021, alongside the In Vitro Diagnostic Medical Devices Regulation. The MDR aimed to raise standards of evidence for high-risk devices, but its central requirement remained vague, asking only for clinical data providing sufficient clinical evidence. Common specifications, which would have set mandatory scientific standards for particular device types, were never realised, apparently due to limited regulatory capacity. Instead, guidance documents issued by the Medical Device Coordination Group are voluntary, interpretation varies between member states, and the type of clinical evidence required for new high-risk devices, whether observational or experimental, is still not defined.

The MDR also created unintended consequences for patients. Massive recertification requirements and unpredictable, protracted conformity assessments drove up costs, and manufacturers withdrew some essential products from the market, including well-established technologies and devices designed for children. A perception spread that Europe had become hostile to device innovation, and the Austrian National Public Health Institute is now monitoring device availability on behalf of the Commission. The scheduled five-year review of the legislation was brought forward after intense lobbying from industry and other stakeholders, culminating in the December 2025 draft regulation. At a High-Level Conference on Medical Devices: Innovation and Patient Safety held in Brussels in March 2026, European Commissioner for Health Olivér Várhelyi declared that a major overhaul was absolutely necessary, but insisted it must come without compromising on patient safety. How to reconcile those goals is the central question of the reform.

One project has supplied much of the evidence base for answering it. CORE–MD, Coordinating Research and Evidence for Medical Devices, was funded by the EU Horizon Europe programme from 2021 to 2024 and led by the European Society of Cardiology together with the European Federation of National Associations of Orthopaedics and Traumatology, with support from the Biomedical Alliance in Europe. Every stakeholder group, including national regulatory agencies and notified bodies, contributed to an extensive review of the system. The consortium confirmed deficiencies in the evidence available for high-risk devices, a dearth of randomised trials and a high risk of bias in many published studies. It proposed a progressive framework matching observational studies and controlled trials to each stage of a device’s life-cycle, and separately described alternative methodologies under the banner of large simple trials, including registry trials and pragmatic studies, which could make rigorous randomised evidence feasible at realistic cost.

The contrast with medicines regulation is instructive. The US Food and Drug Administration and the European Medicines Agency both implement scientific approaches to support regulatory decision-making, whereas for devices the EU has emphasised interpretation of legal rules applied by a patchwork of independent organisations. The authors argue that reform should set explicit standards for demonstrating clinical efficacy where needed for high-risk therapeutic implants, while retaining simpler safety and performance requirements for low-risk devices. Clinical evidence should represent women as well as men, and safe, effective technologies should be equitably accessible to all patients, including children and those with rare conditions. The in vitro diagnostics regulation needs its own tailored policies rather than a copy of the device framework: the authors call for relaxed restrictions on sharing laboratory-developed tests between health institutions, and for the abolition of IVDR Article 5.5 d, which forbids use of an in-house test if an equivalent CE-marked product exists, a rule they say stifles diagnostic innovation in favour of market monopolies.

The European Medicines Agency is set to play a much larger role. The MDR already established Expert Panels of independent clinicians and scientists who provide non-binding opinions on notified bodies’ clinical evaluations of selected high-risk devices. The Screening Panel has judged that roughly ten per cent of high-risk submissions require a full scientific opinion; sixteen have been published, most identifying deficiencies in clinical evidence, yet every reviewed device was still granted market access, prompting calls for transparency about how notified bodies act on expert recommendations. A recent analysis of thirty-four opinions found that nearly half of expert comments concerned the sufficiency of clinical evidence supporting benefit–risk determinations. Under the draft regulation, the panels’ remit will expand to advising the Commission, member states, notified bodies and manufacturers, contributing to guidance and common specifications, and designating breakthrough and orphan status for promising devices. The authors welcome this but warn that delivery is impossible without major investment: the Commission unit coordinating the regulations has only one medically qualified officer, while notified bodies employed 4,099 full-time staff in conformity assessment in 2025.

The deeper prescription is cultural as much as legislative. The authors endorse a definition of regulatory science as the use of scientific approaches to determine which policies and standards best assure safety and efficacy, so that approved technologies improve individual outcomes and public health without disproportionate over-regulation. They want regulatory science to become a recognised subspecialty for clinicians, laboratory scientists, epidemiologists, statisticians and engineers, supporting the EMA and notified bodies alike, with medical associations supplying high-quality evidence from comprehensive device registries. CORE–MD insights already shaped consensus recommendations submitted to the Commission by the Biomedical Alliance on behalf of thirty-five professional associations. Among their warnings: easing conditions for establishing equivalence would repeat a mistake that caused major problems under the old directive, and deleting the standard of sufficient clinical evidence risks more subjectivity rather than consistency. A new high-risk implantable, they argue, should not enter an existing class without a randomised trial against an active comparator or evidence from objective performance criteria. With equivalent standards promoted globally through the International Medical Device Regulators Forum, Europe has a chance to break free from recurrent legislative revisions, if it commits to funding regulatory science as a public good.

Subject of Research: Reform of the European Union regulatory framework for medical devices and in vitro diagnostics

Article Title: Empowering regulatory science for medical devices in Europe

Article References: Empowering regulatory science for medical devices in Europe. (n.d.). https://doi.org/10.1016/j.lanepe.2026.101876

Image Credits: AI Generated

DOI: 10.1016/j.lanepe.2026.101876

Keywords: medical devices, EU regulation, MDR, IVDR, notified bodies, European Medicines Agency, regulatory science, CORE-MD, clinical evidence, in vitro diagnostics, CE-marking, patient safety