Accelerating Access: The New Era of Breakthrough Medical Devices

The emergence of the European Union’s Breakthrough Medical Devices (BtX) program marks an important milestone for medical device regulation in Europe, establishing a formal pathway intended to support the development and review of innovative technologies. With the publication of MDCG 2025-9 in December 2025 and the European Medicines Agency’s (EMA) BtX pilot program launch in April 2026, Europe has demonstrated a clear intent to support novel devices that address unmet medical needs or offer meaningful advantages over existing technologies. 

Similar to the U.S. Food and Drug Administration (FDA) Breakthrough Devices Program, the EU framework emphasizes novelty, unmet medical need, and the potential for significant clinical impact. Both programs aim to foster earlier, more structured dialogue with regulators, prioritize review activities, and improve predictability for manufacturers. Although the EU BtX program is still new and the U.S. reimbursement landscape associated with Breakthrough Designation continues to evolve, both pathways reflect a broader effort to make regulatory systems more responsive to meaningful medical device innovation.

At a high level, the FDA program remains the more mature and operationally proven model. Established under Section 515B of the federal Food, Drug, and Cosmetic Act, the Breakthrough Devices Program has become a central component of FDA’s innovation strategy. Beyond priority review, manufacturers may gain access to sprint discussions, data development planning, clinical protocol agreements, and more frequent interactions with senior FDA management.¹ Submission requirements for Breakthrough Designation include: 

• Device Description
• Proposed Indication for Use
• Regulatory History
• Description of how the device meets Breakthrough Device criteria

o Life-threatening or irreversibly debilitating disease or condition

o How the device represents a Breakthrough technology, has no approved or cleared alternatives that exist in the U.S., offers significant advantage over existing alternatives, or the availability of the device is in patients’ best interest

o For more effective treatment or diagnosis, preliminary evidence demonstrating a reasonable expectation of technical and clinical success is needed (may include literature or preliminary bench, animal, or clinical data)

• Type of marketing submission to be submitted to the FDA

The FDA has also introduced complementary initiatives, including the Safer Technologies Program (STeP), which extends many Breakthrough-like benefits to devices that address less severe conditions but offer significant safety improvements.² In addition, the Total Product Life Cycle Advisory Program (TAP) was developed to help expedite patient access to innovative medical devices and is available to Breakthrough-designated and STeP devices that meet the program’s requirements, including early development stage (e.g., no pre-submissions, not yet initiated a pivotal study).³ 

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The EU BtX framework, by contrast, is still in its early stages. MDCG 2025-9 establishes eligibility criteria and outlines potential benefits, including early scientific advice, structured engagement with expert panels, accelerated conformity assessment activities, and potential access to European funding opportunities. The program is currently operating as a pilot, with the first phase open to Class III devices and Class IIb active devices intended to administer or remove a medicinal product. The EMA has stated that the pilot is intended to test the new regulatory pathway before broader implementation. As a result, questions remain regarding how consistently BtX designation will be granted by the EMA, whether notified bodies will have sufficient resources to deliver an accelerated review, the potential for shorter timelines, and whether the framework will ultimately be incorporated into future MDR and IVDR revisions. The second phase is expected to begin in Q1 2027, when BtX designation and advice requests are anticipated to become available to all medical device classes. A third phase, anticipated in Q3 2027, is expected to open the program to in-vitro diagnostics (IVDs).⁴ Submission requirements for BtX Designation include: 

• Device Description
• Proposed Indication for Use
• Detailed Justification for BtX (i.e. novelty and positive clinical impact with supporting evidence)

o Novelty may relate to materials, design, manufacturing process, sustainability, mechanism of action, biomarkers, portability, automation, site of application, intended purpose/indication, intended user, mode of application, interface/interaction of patients/users, and/or other device features

o Positive clinical impact may be on an individual or population level relating to diagnosis, treatment, clinical outcomes, provision of care, cost-effectiveness, risks, hazards, vulnerable populations, and/or other factors

• Description of Disease/Condition
• State-of-the-Art Analysis
• Supporting Data (a complete set of clinical data is not required at the time of designation, but a reasonable expectation the device could perform as intended and is more effective compared to available alternatives should be provided)

Perhaps the most notable divergence between the two programs is no longer limited to regulatory review but extends into reimbursement and market access. Historically, FDA Breakthrough Device Designation was often viewed as carrying meaningful U.S. reimbursement advantages. Programs such as New Technology Add-on Payments (NTAP) and Transitional Coverage for Emerging Technologies (TCET), which were intended to support timely and predictable Medicare coverage for certain new medical technologies, reinforced the perception that Breakthrough designation could accelerate not only regulatory review, but also payment and adoption. More recently, however, policy developments have begun to reshape the reimbursement landscape for Breakthrough Devices. In April of this year, CMS and FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, which is intended to align regulatory and coverage evidence expectations earlier in development and accelerate Medicare coverage decisions for certain Breakthrough Designated devices, including Class II products participating in TAP and Class III devices.⁵ At the same time, CMS proposed eliminating the longstanding NTAP alternative pathway that had allowed Breakthrough innovations to access add-on payments without independently demonstrating substantial clinical improvement. Together, these policy updates suggest that Breakthrough designation alone may no longer be sufficient to secure favorable reimbursement outcomes; manufacturers may increasingly need to demonstrate measurable clinical value to both regulators and payers.

The number of FDA Breakthrough Device Designations granted has increased substantially over time, from 11 in 2015 to 164 in 2025 and 80 granted as of March 31, 2026.⁶ As request volume grows and resources remain limited, the FDA may need to be increasingly selective in the way it applies Breakthrough designation while also relying on complementary initiatives to support a broader range of innovative technologies. This raises a practical question for both regulators and manufacturers: How can agencies keep pace with rapid medical device innovation while continuing to accelerate access within programs constrained by review capacity, evolving evidentiary expectations, and competing public health priorities? For manufacturers, the question is equally important. If U.S. Breakthrough designation becomes less directly tied to predictable reimbursement advantages, and if the EU BtX framework remains a pilot with benefits that are still being defined, manufacturers will need to decide how to balance the added investment in these pathways against the strategic value of early regulatory engagement.

Ultimately, both the FDA Breakthrough Devices Program and the EU BtX initiative are aimed at the same goal—helping patients gain earlier access to innovative medical technologies. The FDA program remains a valuable and well-established model, offering manufacturers prioritized review and earlier, more structured interactions with FDA experts. The EU BtX pilot is also a positive step forward, demonstrating a clear commitment by European regulators to create a more innovation-friendly pathway that can help novel technologies reach patients faster while maintaining appropriate standards for safety and performance. Although questions remain regarding BtX implementation, early participation may give manufacturers an important opportunity to engage while the framework is still taking shape. Manufacturers that move now may be better positioned to influence regulatory expectations, contribute to the practical evolution of the pathway, and demonstrate the clinical value of their technologies in programs increasingly focused on meaningful patient benefit. In that sense, Breakthrough designation in both the U.S. and EU should be viewed not simply as a regulatory designation, but as a strategic opportunity for manufacturers to accelerate development, support earlier patient access, and bring meaningful innovations to market more efficiently.

References

1. bit.ly/4yZzkUY
2. bit.ly/4fNtRYh
3. bit.ly/45EFlZw
4. bit.ly/4xjd5HJ
5. bit.ly/4q3U1eb
6. bit.ly/3TCMW8f

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Somi Ekwealor collaborates with cross‑functional stakeholders to develop and execute robust regulatory strategies for novel robotic medical devices. Before joining MCRA, an IQVIA business, he worked for fortune 500 companies and startups for 14 years. He is a Regulatory Affairs Certified (RAC) professional.

Alexandra Schardt has more than eight years of medtech industry and medical device regulatory affairs experience. She is RAC-certified in medical device regulatory affairs. Before joining MCRA in 2021, Schardt worked in viral vector product development at a privately held biotechnology company.