Rethink Your EU Breakthrough Device (BtX) Strategy

The EU has historically lacked a dedicated framework for breakthrough medical technologies.

While MDR and IVDR are technology-neutral, their implementation has proven challenging for novel technologies without comparable ones, or devices addressing rare or high-risk conditions or early-stage innovations lacking extensive clinical data.

The new guideline MDCG 2025-9 addresses this gap by establishing a common interpretation framework for evaluating innovative devices while maintaining high standards of safety and performance.

So, what exactly is a BtX device in the EU?

For a device to be considered a BtX, it needs to meet both ¹ of these criteria:

Of note, the breakthrough status does not reduce regulatory requirements. The BtX is not a new classification, nor a fast-track approval pathway, nor an exemption from MDR/IVDR obligations.¹

Early and Structured Regulatory Engagement

Manufacturers are encouraged to engage early with notified bodies, competent authorities and expert panels, which facilitates the alignment on clinical strategy and early identification of regulatory risks.

Early and structured engagement with notified bodies, competent authorities, and expert panels, as outlined in MDCG 2025-9, can substantially reduce regulatory uncertainty from the outset of development. By aligning clinical strategy, evidence requirements, and risk-mitigation approaches early, companies gain clearer visibility into what will be expected for conformity assessment and eventual market access. This upfront clarity helps prevent costly redesigns, delays, and unsuccessful submissions, key factors that make regulatory pathways appear high-risk.

For companies, and especially startups, this creates a more predictable development trajectory, strengthens credibility during due-diligence evaluations, and demonstrates a de-risked route toward CE marking. As a result, BtX can enhance investment readiness, shorten timelines, and build confidence among both internal decision-makers and external investors. ^{1 2}

It will also be important to observe how notified bodies implement this early-engagement model in practice, given their strict prohibition on providing consultancy. The guidance encourages more interaction, but the boundaries between permissible clarification and impermissible advice will need to be carefully managed to ensure both regulatory efficiency and continued independence of conformity-assessment activities.

Prioritization of Assessment

While MDCG 2025-9 indicates that BtX devices may benefit from prioritized review timelines and more focused interactions with regulators, it remains to be seen how this prioritization will be implemented in practice. The guidance signals an intention to streamline assessments for high-impact or innovative technologies, but the concrete mechanisms, such as resource allocation, review queues, or defined fast-track criteria, have not yet been detailed. Clarity on these operational aspects will be essential for companies, particularly startups, to understand how much acceleration they can realistically expect and how to integrate these potential efficiencies into their development and regulatory planning.

Flexible Evidence Generation

The framework supports a lifecycle-based approach: during pre-market one can demonstrate acceptable benefit-risk, and later in post-market generate confirmatory evidence. This flexibility is particularly relevant for AI-driven devices, precision medicine applications, and CDx and biomarker-driven diagnostics. ^{1 3}

It is encouraging to see this flexible evidence-generation model formally recognized, as it acknowledges that certain innovative technologies, especially those addressing unmet medical needs, may require post-market data to fully confirm clinical performance. Allowing part of the evidence package to mature after market entry can clearly accelerate access for patients while maintaining a controlled, lifecycle-based oversight framework.

Looking ahead, it will be important to observe how notified bodies interpret and operationalize this flexibility in practice. A key question will be how they define the acceptable level of pre-market evidence needed to support a positive benefit-risk determination, and whether these thresholds will be applied consistently across different notified bodies.

Despite its advantages, BtX introduces several challenges:

• Increased reliance on post-market data, as it requires strong data infrastructure and long-term follow-up strategies;
• Notified body capacity; ²
• Lack of formal acceleration, i.e. no guaranteed timelines (as opposed to FDA pathways)

The European Medicines Agency (EMA) launched a pilot programme in April 2026 to establish a structured pathway for expert panel support to manufacturers and notified bodies involved in breakthrough medical devices (BtX). ⁴ The pilot is designed to:

• Facilitate early, high-quality scientific and regulatory advice for innovative medical devices
• Support designation and development of "breakthrough" devices
• Accelerate patient access to technologies addressing unmet medical needs, while maintaining robust safety and performance requirements
• Designation support: Guidance on whether a device qualifies as a breakthrough device
• Development and conformity support: Advice on implementing regulatory guidance

The programme will run in 3 phases (see table below) and provides free expert panel advice in two main areas:

This pilot will be particularly valuable in helping regulators and notified bodies identify bottlenecks, refine processes, and calibrate expectations before full-scale deployment. It will give manufacturers of designated BtX devices access to priority scientific advice from EMA expert panels, beginning with an initial application window in May 2026. The outcomes of the pilot will ultimately shape how the BtX pathway is harmonized and integrated into routine conformity-assessment workflows.

It will be important to observe how the BtX framework is implemented and progressively refined based on feedback from the ongoing pilot phase, which will serve as the first real-world test of the model. This pilot is expected to generate practical insights into how flexible evidence generation, early engagement, and prioritization mechanisms operate in actual regulatory interactions. As experience accumulates, the framework may be adjusted to improve consistency, predictability, and operational feasibility across the EU.

Compared to the FDA Breakthrough Device Program (US), the EU BtX focuses on lifecycle flexibility and emphasizes post-market evidence, while the FDA focuses on accelerated pre-market review. Key differences are summarized in the table below. ^{1 5 6}

Success under the BtX framework depends on early planning, strong regulatory engagement, and a robust post-market strategy. The following recommendations are organized for manufacturers evaluating BtX potential or already pursuing designation.

1. Identify BtX potential early. Assess the degree of novelty and the positive clinical impact vs. state of the art.

2. Engage your Notified Body through Structured Dialogue.

3. Engage regulators proactively. Seek early advice for clinical development plans and evidence strategy.

4. Design lifecycle-based evidence plans. Combine pre-market studies with PMS/PMCF/PMPF from the outset.

5. Strengthen post-market capabilities. Invest in data collection systems and real-world evidence infrastructure.

6. Align global regulatory strategies. Coordinate EU BtX with, for example, the FDA Breakthrough Device Program for US market access.

Key implications by manufacturer type:

MDCG 2025-9 represents a significant evolution in the European regulatory landscape, introducing, for the first time, a structured framework designed to both encourage innovation and maintain rigorous safety and performance standards, while enabling earlier patient access to high-impact technologies.

For manufacturers, the key shift is from "How much evidence do we need before market?" to "How do we strategically generate evidence across the product lifecycle?" This lifecycle-based approach places greater emphasis on the integration of pre-market and post-market evidence, aligning regulatory expectations with the realities of developing novel technologies. Success under this framework will depend on early planning, strong regulatory engagement, and a robust post-market strategy. But do remember: the BtX designation does not make approval easier - it makes innovation more feasible by redefining when and how evidence is generated.

Despite its strategic value, the number of BtX designations within the European Union is expected to remain limited, likely restricted to a small number of devices each year. This contrasts sharply with the U.S. FDA's Breakthrough Devices Program, which routinely grants more than one hundred designations annually. This stark difference reflects structural and operational realities: the EU system relies on multiple notified bodies with uneven capacity, limited expert-panel throughput, and no centralized review authority equivalent to the FDA. In contrast, the FDA operates a single, well-resourced, centralized program with dedicated staff and established fast-track procedures. The EU's stricter separation between assessment and consultancy, combined with already stretched notified-body resources, further constrains throughput. As a result, BtX is expected to be highly selective, focusing on a very small number of devices addressing clear unmet medical needs, while the U.S. system can accommodate a much larger volume of breakthrough designations.

Looking ahead, the introduction of BtX is a positive signal for European innovation, offering a more agile and forward-looking regulatory mindset. Consultancy organizations such as Veranex may play a valuable role in helping manufacturers prepare high-quality evidence packages, structure early engagement materials, and facilitate productive discussions with notified bodies, while staying within the boundaries of what NBs can legally provide. This collaborative ecosystem could ultimately help accelerate safe, meaningful innovation for patients across Europe. Furthermore, the increased acceptance of lifecycle-based evidence generation suggests a broader regulatory trend, which may, over time, be reflected in future revisions of both the MDR and IVDR regulations.