EMA Launches Pilot Program for Breakthrough Medical Devices
The European Medicines Agency (EMA) has started accepting applications for a pilot program of expert evaluation for breakthrough medical devices (class III and IIb). The program aims to accelerate market access for innovations in cardiovascular and pediatric technologies.
Some may have noticed, but on April 28, 2026, the European Medicines Agency (EMA) launched the first phase of a pilot program for breakthrough medical devices. The news sounds like a routine bureaucratic initiative—the regulator opened applications for five slots, prioritizing cardiovascular and pediatric technologies. In reality, something deeper lies beneath: Europe acknowledges that its main regulatory asset—safety standards—has become a brake on innovation, and it is now launching a mechanism that could shift the balance of power between the FDA and European notified bodies for the next decade.
The Essence: What Is Really Happening
EMA is testing a fundamentally new model for Europe in interacting with medical technology developers. Until now, the European system operated on a rigid logic: the manufacturer independently prepares a dossier, a notified body reviews it, and only after obtaining CE marking does the device enter the market. The regulator does not consult, advise, or guide—it evaluates the final result. This is a fundamental difference from the FDA's approach, which, through its Breakthrough Devices Program, actively engages with developers at early stages, helping shape clinical trial designs and evidence requirements.
Now EMA is launching its own counterpart. The pilot program allows manufacturers of class IIb and III devices to obtain breakthrough status and free consultations from expert panels on preclinical data, clinical strategy, and post-market surveillance. The expert panels are composed of independent scientific, technical, and clinical specialists and are administered by EMA. Applications for the first phase are accepted until May 22, 2026, from which five will be selected, with one device already in the conformity assessment stage. Participation is completely free.
This is not an educational seminar or a relaxation of standards. It is a structural test of an alternative regulatory pathway where the manufacturer gains predictability at the most expensive stage of development—the clinical stage.
Timeline and Context
The pilot did not emerge in a vacuum. Its roots go back to December 2025, when the European Commission published a proposal to revise the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This proposal introduced new articles 52a MDR and 48a IVDR, establishing adaptive certification procedures for breakthrough technologies. The proposal explicitly acknowledged a regulatory gap: the current system lacks special pathways for highly innovative devices.
Simultaneously, the Medical Device Coordination Group (MDCG) issued guidance MDCG 2025-9, defining criteria for breakthrough technology: a high degree of novelty and significant positive clinical impact—either through superiority over existing alternatives or by addressing an unmet medical need.
But the most important context is the crisis in the European certification system. The MDR, fully effective in May 2021, created massive delays in device evaluation. In February 2026, Member of the European Parliament Cynthia Ní Mhurchú submitted a formal request to the Commission, stating that these delays "hinder EU patients' access to well-established medical technologies." This referred to cases where devices used in over a million patients worldwide and manufactured in the EU could not obtain CE marking despite fully prepared documentation.
The response to this crisis was the EMA pilot. It attempts to solve the problem from two sides: accelerate market access for truly innovative devices and simultaneously create a precedent for future legislative reform. Officially, the program will run until 2027 in three phases: first (class III and IIb)—now; second (all device classes)—from Q1 2027; third (including IVD)—from Q3 2027.
Who Wins and Who Loses
Winners:
Investors in European medtech startups at seed and Series A stages. The main risk deterring capital from European medical projects is the unpredictability of the regulatory path and time to market. The EMA pilot gives these companies the opportunity to obtain expert opinions on clinical programs years before submitting for certification. For a startup raising €20–50 million in venture funding, a letter from an EMA expert panel confirming the adequacy of the clinical strategy is an argument that can reduce the cost of capital by 2–4 percentage points and accelerate the round by three to six months. HSBC Innovation Banking noted in its Q1 2026 report that the median capital raised and valuations in the medical device sector are growing, and investors "prefer quality over quantity, selectively supporting companies with clear paths to value creation."
Manufacturers of cardiovascular surgery and pediatric devices. EMA explicitly prioritized these two categories in the first phase. This is not a random choice: cardiovascular diseases remain the leading cause of death in the EU, and pediatric devices have historically suffered from a lack of innovation due to small market size and the complexity of clinical trials in children. Companies in these segments gain a window of opportunity: even if their device is not among the five selected, they can reapply in phase Ib as early as Q3 2026.
Law and consulting firms specializing in regulatory support for medical devices. Hogan Lovells has already published two detailed analyses of the pilot, and demand for such consultations will grow exponentially as the program expands. The cost of preparing a breakthrough status application package can easily range from €50,000 to €150,000, depending on device complexity.
Losers:
Notified bodies. In the current system, they are the monopoly gatekeepers to the European market. Every class IIb and above device must pass their evaluation, and they bear full responsibility for the certification decision. The pilot introduces a parallel influence structure: the EMA expert panel can provide recommendations that the manufacturer brings to the notified body, effectively limiting the latter's discretion. Moreover, it is specifically stipulated that in the first phase, the notified body will be involved in the consultation request for one of the five selected devices. This means EMA is testing a model where the notified body is not the sole arbiter but a participant in a broader regulatory process.
US device manufacturers accustomed to FDA preferences. If the pilot succeeds and becomes a permanent procedure under the new MDR articles, the European market will become significantly more accessible for innovative products from global companies. This means increased competition for placement in European clinics, potentially pressuring margins for US manufacturers in their traditionally profitable export market.
Companies producing "me-too" devices with minimal improvements. The two clear criteria for breakthrough status—high novelty and significant positive clinical impact—create a formal boundary between innovators and optimizers. Devices offering minor improvements will not gain access to priority consultations, and their path to market will remain standard, with queues and delays. This is a deliberate policy: the regulator signals to the market that resources are limited and will be directed where the public benefit is highest.
What the Media Isn't Saying
First and foremost: this pilot is a direct consequence of Europe's fear of technological lag. Throughout 2024–2025, European medical technology manufacturers repeatedly stated that the FDA's Breakthrough Devices Program processes innovative applications significantly faster than the European system. There was a risk that cutting-edge technologies would appear on the US market two to three years earlier than in Europe, creating not just a medical but also an economic problem: European hospitals would become secondary access markets. The media doesn't write this, but within the industry, everyone understands: the pilot is an attempt to catch up with the FDA without lowering the safety bar.
Second: the connection to the EU Biotech Act, which most news articles don't even mention. In its official press release, EMA explicitly states that the pilot "aligns with the goals of the EU Biotech Act to create an innovation-friendly regulatory environment and accelerate the development and deployment of advanced medical technologies for patients in the EU." This means the pilot is not an isolated initiative but part of a much broader European Commission strategy to stimulate the biotech sector. This strategy also includes simplifying clinical trials, tax incentives for R&D, and creating a European counterpart to BARDA. Investors reading the EMA press release without this context see a small program for five devices. Those aware of the EU Biotech Act see the first brick of a new architecture.
Third: the free nature of consultations is a weapon, not a bonus. EMA emphasizes that participation in the pilot is free. But this is not charity. Free expert consultation removes the financial barrier for small and medium-sized enterprises that otherwise could not afford deep regulatory support at early stages. This is a deliberate leveling of the playing field: a startup from Portugal with an annual budget of €2 million and a US corporation with a 50-person regulatory department now have access to the same level of expertise. For large manufacturers, this is more of a disadvantage—their competitive advantage in regulatory muscle is partially eroded.
Fourth: the pilot tests a system that, in the long term, could change the very concept of the "European medical device market." Currently, it is fragmented: CE marking grants access to all 27 EU countries, but procurement and reimbursement decisions are made at the national level. However, an EMA recommendation on breakthrough status is an EU-wide document, and it will inevitably be considered by national HTA bodies and payers. Devices that go through the breakthrough track will gain not only regulatory acceleration but also a stronger negotiating position when discussing price and access at the national level. This could potentially shorten the path from certification to actual clinical use by 6–18 months.
Forecast: Next 30 Days and 90 Days
30 days (by June 5, 2026):
The application window for phase Ia closes on May 22. In the last week before the deadline, a surge of submissions is expected—manufacturers who have been consulting with lawyers over the past two to three weeks will finalize their documents. By June 5, EMA will likely announce the number of applications received, and this number will be a crucial indicator of demand. If applications number 50–80, it will confirm that the industry has taken the pilot seriously. If fewer than 20, it means the market has adopted a wait-and-see approach, and EMA will need to adjust its communication.
During this period, the content of closed negotiations between major manufacturers and notified bodies on how the latter will incorporate breakthrough opinions from expert panels will also become known. These are informal discussions, but their outcomes will determine whether the pilot becomes a real accelerator or a bureaucratic addition to existing procedures.
90 days (by August 5, 2026):
The decision on the five selected applicants for phase Ia will likely be made in late June or early July. By August, not only the company names but also the types of devices that received breakthrough status will be known. These five devices will become the program's showcase. Their fate over the next 12–18 months—whether they obtain CE marking and how quickly—will determine whether the pilot becomes a permanent mechanism or remains an experiment.
Phase Ib starts in Q3 2026, and I expect EMA to use it to expand the geographic diversity of participants. If in phase Ia most applicants are from Western Europe and the US, phase Ib will open a window for companies from Central and Eastern Europe, as well as Israel and South Korea—countries with strong medtech sectors but limited experience with European regulatory structures.
Key strategic forecast for the 90-day horizon: the European Parliament will begin informal consultations to accelerate the legislative process for new articles 52a MDR and 48a IVDR. If the results of the first pilot round are perceived positively, the Commission may present an accelerated adoption timeline, bypassing the standard three-year negotiation cycle. In that case, the breakthrough track could become a permanent procedure not in 2029–2030 but as early as 2027.
— Editorial Team
