The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and enhanced communication with regulators. Despite its promise, only a small percentage of devices granted Breakthrough designation have achieved marketing authorization, reflecting persistent regulatory and evidentiary hurdles.
In parallel, the European Commission has put forward a proposal for a Breakthrough Devices designation that seeks to accelerate market access for innovative technologies. This is part of proposed changes to simplify Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR) and reduce some of the regulatory burden for companies.
Both pathways offer meaningful opportunities for expedited review and increased regulatory interaction. However, significant hurdles remain in achieving market access and securing reimbursement, with each program imposing substantial evidentiary and resource demands. This blog post reviews the advantages, disadvantages, and practical implications of the Breakthrough designation for device manufacturers, investors, and other stakeholders in the US and under the EU proposal.
FDA’s Breakthrough Devices Program
FDA’s Breakthrough Devices Program is designed to expedite development and review of medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. To qualify, such devices must also meet secondary criteria related to clinical impact and innovation, such as representing breakthrough technology or fulfilling an unmet medical need.
Key advantages of the program include the following:
- Prioritized FDA review, potentially reducing regulatory delays and expediting patient access
- Increased interaction with FDA, which may clarify requirements and streamline the review process
- Opportunities for expedited Medicare coverage through programs such as Transitional Coverage for Emerging Technologies (TCET)
- Enhanced visibility for investors, with Breakthrough designation signaling potential for authorization and reimbursement
However, significant disadvantages persist, including the following:
- Breakthrough designation of a device is not necessarily an indicator of future premarket authorization with only a small percentage of Breakthrough-designated devices receiving marketing authorization, to date.
- Increased FDA involvement can lead to more stringent evidence requirements and complex clinical trial expectations for the premarket submission, potentially increasing time and cost to market, which can be particularly challenging for smaller companies and devices for rare indications with a small clinical population.
- Substantial time and resources are required to obtain Breakthrough designation, acceptance into the program is not guaranteed, and FDA’s resources can be a limiting factor on the number of Breakthrough designations granted in a particular year.
- Devices must be sufficiently developed to qualify for the Breakthrough program. FDA expects Breakthrough candidates to be beyond the concept phase and have early performance data supporting technical feasibility and clinical benefit.
- The program may not benefit devices eligible for the 510(k) process, as data shows little reduction in review time for these submissions.
On the reimbursement front, the TCET pathway provides limited opportunities for early Medicare access for Breakthrough-designated devices due to its annual cap (only five Breakthrough devices are admitted into the pathway annually) and strict eligibility criteria. Many digital health technologies are excluded due to lack of a Medicare benefit category.
Additionally, continued Medicare coverage of devices under TCET is not guaranteed. Devices in the TCET program are subject to ongoing evidence generation requirements and eventually need to provide evidence to support more permanent Medicare coverage. Other reimbursement policy solutions focused on FDA-designated Breakthrough devices have been floated, including by FDA’s commissioner, but have yet to materialize.
Most recently, the Ensuring Patient Access to Critical Breakthrough Products Act, a bipartisan bill intended to provide temporary Medicare coverage for authorized Breakthrough medical devices while companies work with the Centers for Medicare and Medicaid Services on more permanent coverage, remains stalled in Congress.
EU’s Breakthrough Devices Pathway Proposal
The European Commission’s proposal defines Breakthrough Devices as those introducing a high degree of novelty and that are expected to provide significant positive clinical impact or fulfill an unmet medical need. If this designation is confirmed by the expert panel, these devices would receive the following:
- Early expert advice on clinical development strategy and appropriate evidence generation for the clinical evaluation of the device
- Prioritized notified body assessment and application of a rolling review to reduce assessment timelines
- Conditional certificates based on more limited clinical data, where immediate availability outweighs risks associated with the fact that additional clinical data is still required, or where the manufacturer commits to providing further post-market evidence
The MDCG 2025-9 Guidance on Breakthrough Devices, published in December 2025, provides a similar policy framework for these devices and largely formed the basis of the proposed changes to the legislation.
If adopted, the Breakthrough designation has the potential to improve the speed of access to transformative technologies in the EU, but this will be linked to greater post-market responsibility and intensified regulatory engagement across the device lifecycle. While the proposal will undergo changes as part of the legislative process, based on the current text, certain advantages and disadvantages can be identified:
- Advantages include:
- Earlier and more predictable regulatory engagement, facilitating alignment and validation of development plans
- Potentially faster patient access
- Prioritized review, which should help to address notified body capacity constraints
- Difficulties include:
- No reduction in the overall data requirements, but an increased reliance on post-market obligations (which could include studies, registries, and regular reporting) and increased monitoring of such commitments
- Added operational complexity due to rolling reviews, conditional certificates and expert panel involvement, which will require coordination across regulatory, clinical, and quality teams
- Absence of market exclusivity or commercial protection; speed is prioritized over other commercial advantages, but the value of this may not be commercially significant if there are delays during the pricing and reimbursement process
Potential Industry Impacts and Recommendations
Given the demanding requirements and uncertain reimbursement landscape in the US, companies should carefully evaluate whether pursuing Breakthrough designation aligns with their device’s intended use, population, and technological novelty. For US market entrants, understanding the robust evidence standards and annual caps of programs such as TCET is critical, as success in obtaining both FDA authorization and Medicare coverage is far from assured.
Early engagement with regulators and strategic planning can maximize the likelihood of success; companies may wish to consult experts to assess whether increased FDA interaction would add value for their specific technology. New entrants into the medical device market also need to be able to weigh the realities of the FDA Breakthrough Designation Program, against the reimbursement potential for FDA-designated Breakthrough Devices, and the cache of being able to tout a product as “Breakthrough” to investors. This analysis is complicated and fact specific.
If Breakthrough designation is part of a company’s reimbursement strategy, stakeholders must recognize the substantial resource demands and the fact that legislative solutions remain politically popular but operationally challenging. Devices with clear predicates or well-understood technology may derive little benefit from the Breakthrough designation, and the opportunity cost of pursuing designation must be weighed against alternative regulatory approaches.
For the EU market, the proposed Breakthrough pathway could offer faster market access, but it also brings increased post-market responsibilities and operational complexity. Should the Breakthrough pathway be adopted, manufacturers should consider Breakthrough eligibility early in product development and plan for robust post-market data collection to complement any gaps in pre-market evidence. It will also be important to monitor how notified bodies implement the current MDCG Guidance on Breakthrough Devices, and whether the regulatory flexibilities lead to practical commercial advantages.
Across both jurisdictions, early strategic planning and proactive engagement with regulators will be essential to navigating the evidentiary requirements, resource commitments, and uncertain reimbursement pathways associated with Breakthrough status.