Lancet Authors Make the Case for an EU Medical Device Agency

Europe needs an EU medical device agency with binding powers over regulatory strategy, guidance and advice, according to a Personal View in The Lancet Regional Health – Europe (Volume 72, January 2027). The authors, Anett Schönfelder and Stephen Gilbert of TUD Dresden University of Technology, Tom Melvin of the University of Galway and Timo Minssen of the University of Copenhagen, say the European Commission’s proposal to simplify the MDR and IVDR, published on December 16, 2025, leaves the core problem untouched: notified bodies still decide, one by one, whether innovative devices reach the market.

The Commission proposal will probably come into force in 2027. Industry, regulators, clinicians, patients and members of the European Parliament have already called for a central EU-level body. The paper’s question is narrower and harder. Which form of centralization would fix the system, and which would only add another layer to it?

A system with no captain

Medical devices in Europe are governed by the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746. For certain devices, conformity assessment runs through notified bodies, and the resulting CE marking is currently valid in over 100 jurisdictions.

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Many actors surround that process. The European Commission chairs the Medical Device Coordination Group (MDCG) through DG SANTE. The European Medicines Agency (EMA) supports the medical device expert panels (EXPAMED), which give scientific opinions on certain high-risk devices. There are 27 national competent authorities and designating authorities, about 53 notified bodies and over 37,000 MedTech companies. The authors describe the result as “high on bureaucracy, but low transparency and effective communication.”

The evidence that Europe is falling behind

The authors argue that Europe is losing ground as a first market for new technology. A 2024 MedTech Europe survey of 211 medical device and IVD manufacturers found that companies deprioritize the EU as their first regulatory market. New innovative product launches in the EU dropped by 33% for large medical device manufacturers and 19% for small ones, and by 40% for large and 12% for small IVD manufacturers. Among SMEs, 59% of IVD and 54.4% of medical device manufacturers reported a decline in the development of new devices.

The paper is just as critical on safety evidence. Data from the CORE-MD consortium showed that 9% of cardiovascular devices and 0% of orthopaedic implants analysed had any pre-market clinical evidence publicly available at the time of marketing. When EXPAMED reviewed clinical evaluations that notified bodies had already accepted, it found flaws ranging from poor study design to insufficient sample sizes and weak post-market evidence plans. In all cases, the products were granted market approval.

Combination products make the rules harder to read. An AI-powered closed-loop insulin system, the authors’ example, falls under medicines, medical device and artificial intelligence rules at once, and overlaps between those regimes slow timelines and produce conflicting decisions. Manufacturers who want early advice have few places to go. Notified bodies are barred from consultancy, and while 57% of national competent authorities offer advice before an application, only 11% offer national scientific advice beyond clinical-trial aspects. There is no publicly accessible database of previous notified body decisions. In a study for the Commission, all the MedTech companies interviewed described an “accountability vacuum.”

The US, by contrast, links binding advice and authorization through the FDA’s Breakthrough Devices Program with the proposed RAPID Coverage Pathway, which would issue a proposed national coverage determination on the same day a breakthrough device receives FDA authorization. EMA’s pilot for breakthrough devices offers priority advice from EXPAMED, but final decisions stay with notified bodies.

What six position papers ask for

Between October 2024 and September 2025, six groups called for a central governance structure. They disagree on its form. All of them would keep notified bodies in place.

Source: Schönfelder et al., Lancet Reg Health Eur 2027, Table 1.

Each group leans on the problems closest to its own interests, the authors note. Clinicians, researchers and patients focus on gaps in clinical evidence and transparency. Industry groups focus on the lack of a single mandated contact point at EU and international level.

What centralization has delivered elsewhere

The authors cite precedents from outside medical devices. After the EU trademark was introduced, securing EU-wide protection cost about €3,160 through separate national filings versus €1,975, a figure that later dropped to less than €600. A study of EMA’s centralized procedure for medicines found that joining it reduced launch delays by 10.9 months. In health procurement, evidence from Denmark and Italy suggests centralization limits waste, including corruption that can inflate costs by up to 11%. They also cite the European Food Safety Authority, founded in 2002 after the BSE crisis, and a study of 745 European banks in which those that moved to centralized supervision reduced their credit risk exposures.

Where centralization can go wrong

The authors accept that centralization is not always the better choice. Decentralization can win where stakeholder preferences are highly heterogeneous, and a central body would not by itself shorten approval times while the current patchwork of legislation still applies. They point to the FDA as a warning. Recent shifts there have been “exceptional,” they write, including reviews that rely on a single pivotal trial instead of two, advisory panels with financial conflicts, and layoffs of experts when expertise in new technologies is much needed.

In their words, “centralization, in itself, is neither a guarantee nor a precondition” of a working approvals and oversight system. Enforceable standards and consistent implementation decide the outcome. They add that no EU medical device legislation since 1990 has been preceded by a scientific evaluation of policy options and their effects on public health.

What the authors propose

Their preferred model is the most centralized option EU law allows: a new Medical Device Agency, or a well-defined division within an existing agency such as the EMA, with high decision-making power over regulatory strategy and guidance. It would need legal powers, expert staff with operational experience and a mandate to define and enforce rules, as the FDA does. Its jobs would include a transparent, open-to-all database of device classifications, binding and recorded advice on innovative devices and clinical development strategies, and evidence-based approval decisions that later decisions inherit as system-level policy. Dashboards on certification throughput or EUDAMED adoption would make the system’s performance visible.

Their risk matrix sets the benefit of pooled expertise (high sectoral impact, moderate likelihood) against the danger of a single point of failure (high systemic impact, very low likelihood). A coordination office is the most feasible option, they concede, but its limited scope and enforcement power make it the least effective for the sector. They propose Centers of Excellence in Regulatory Science and Innovation, based on the US and UK model, to feed academic evidence into central decisions, and a fail-fast culture in place of the assumption that reform will be “right first time.”

Current proposals, the Commission’s included, risk combining “the worst aspects of centralised and decentralised approaches,” the authors write. If the EU settles for a partially decentralized “half-way-house,” they want it to know that model’s weaknesses and limit their effects.

Source: Schönfelder A, Melvin T, Minssen T, Gilbert S. Reforming medical device regulation in Europe: centralization, governance, and the case for an EU medical device agency. Lancet Reg Health Eur. 2027;72:101908.