Bioexcelife
In 2025, the Medical Device Coordination Group (MDCG) released MDCG 2025-9, a new guidance introducing a structured EU framework for Breakthrough Devices (BtX) under EU MDR (2017/745) and IVDR (2017/746).
This guidance is a major step toward supporting innovative, high-impact medical devices, while still maintaining strong safety and clinical evidence requirements.
If you are developing a novel or transformative device, this guidance is highly relevant.
What Are Breakthrough Devices (BtX)?
Under MDCG 2025-9, a Breakthrough Device (BtX) is defined as a medical device or IVD that:
- Introduces a high degree of novelty, and
- Is expected to deliver a significant positive clinical impact, particularly for:
- life-threatening conditions
- irreversibly debilitating diseases
- unmet medical needs where no adequate alternatives exist
The BtX concept is designed to encourage innovation while ensuring patient safety.
Why Did the EU Introduce BtX Guidance?
Innovative devices often face challenges under standard conformity assessment routes due to:
- Limited clinical data at early stages
- Novel technologies without direct comparators
- High development costs and long timelines
MDCG 2025-9 addresses this gap by providing regulatory flexibility, without compromising safety or performance.
Key Highlights of MDCG 2025-9
1️⃣ Clear Criteria for BtX Designation
The guidance outlines assessment criteria based on:
- Degree of novelty
- Expected clinical benefit
- State of the art and available alternatives
- Public health relevance
This ensures consistent evaluation across the EU.
2️⃣ Early & Structured Interaction With Regulators
Manufacturers of potential BtX devices are encouraged to engage early with:
- Notified Bodies
- Competent Authorities
This helps clarify expectations on clinical evidence, study design, and conformity routes at an early stage.
3️⃣ Proportionate Clinical Evidence Approach
For BtX devices, the guidance allows flexibility in pre-market clinical evidence, where justified.
This may include:
- Greater reliance on PMS, PMCF, or PMPF data
- Phased or adaptive clinical evidence generation
- Real-world evidence post-market
However, safety and performance must still be demonstrated.
4️⃣ Strong Emphasis on Post-Market Surveillance
While pre-market flexibility is possible, BtX devices require:
- Robust PMS systems
- Well-defined PMCF/PMPF plans
- Continuous benefit–risk evaluation
Post-market data becomes a critical pillar of compliance.
5️⃣ Pilot Programme Expected
The guidance indicates that a BtX pilot programme is expected to be rolled out around Q2 2026, allowing manufacturers to test this framework in practice.
What This Means for Medical Device Manufacturers
For manufacturers working on innovative technologies, MDCG 2025-9 offers:
- Faster and clearer regulatory pathways
- Reduced uncertainty for novel devices
- Earlier market access possibilities
- Better alignment between innovation and regulation
However, this is not a shortcut. Manufacturers must still:
- Justify BtX eligibility
- Maintain strong risk management
- Commit to intensive post-market follow-up
Who Should Consider the BtX Pathway?
This guidance is especially relevant for:
- First-in-class medical devices
- AI-based or digital health technologies
- Devices targeting rare or critical conditions
- Products addressing unmet clinical needs
If your device significantly changes how a disease is diagnosed, treated, or managed, BtX may apply.
Conclusion: A Positive Step for Innovation Under EU MDR
MDCG 2025-9 marks a strategic shift in EU regulation, recognizing that innovation needs regulatory support, not just control.
By introducing the Breakthrough Device (BtX) framework, the EU aims to:
- Encourage innovation
- Support early patient access
- Maintain high safety and performance standards
Manufacturers developing novel devices should start evaluating whether their products could qualify as BtX — and begin planning early regulatory and clinical strategies accordingly.
