New EU Guidance on Breakthrough Devices & IVDs

In December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9, a new guidance document introducing a structured EU framework for Breakthrough Medical Devices and In Vitro Diagnostic Devices (BtX) under the MDR and IVDR.  

Insights on the New EU MDCG Guidance

The new guidance aims to facilitate earlier patient access to highly innovative technologies that address life-threatening or irreversibly debilitating conditions, while maintaining robust standards for safety, performance, and clinical evidence. 

What is a Breakthrough Device (BtX)? 

A device may qualify as a Breakthrough Technology if it: 

• Demonstrates a high degree of novelty (e.g. first-in-class technology, paradigm-shifting innovation), and 

• Is reasonably expected to deliver a significant positive clinical impact on patient or public health compared with the current state of the art or addresses an unmet medical need. 

BtX designation can apply to both medical devices (BtMD) and IVDs (BtIVD) across all risk classes and technologies. 

Key Regulatory Implications for Manufacturers 

The guidance introduces a proportionate, lifecycle-based approach to clinical evidence generation, recognizing that highly novel devices may face greater uncertainty early in development. Key elements include: 

• Early designation of BtX status, potentially years before CE marking. 

• A balanced pre-market vs post-market evidence strategy, allowing certain confirmatory data to be collected through enhanced PMS and PMCF/PMPF. 

• Increased emphasis on robust non-clinical and pre-clinical evidence to mitigate uncertainty. 

• Clear expectations for risk management, usability engineering, and lifecycle evidence planning. 

Access to Expert Panels and Regulatory Support 

Manufacturers of designated BtX devices can benefit from: 

• Priority scientific advice from EMA expert panels, including early advice on clinical and performance study design. 

• Structured and prioritized dialogue with Notified Bodies. 

• The possibility of certification with specific conditions, linked to defined post-market data generation milestones. 

• Enhanced regulatory predictability, particularly for SMEs 

Strengthened Post-Market Surveillance 

BtX devices are expected to operate under enhanced PMS and PMCF/PMPF frameworks, including: 

• Milestone-based post-market studies 

• Use of registries and real-world data 

• More frequent reassessment of benefit-risk by Notified Bodies 

• Increased transparency via labelling, IFUs, SSCP/SSP, and EUDAMED 

Transparency and Public Oversight 

The guidance introduces new transparency expectations, including: 

• Clear communication of BtX status to users and patients 

• Public traceability via EUDAMED 

• Planned development of an EU-level BtX public dashboard covering designation, certification, and market access 

Why this Guidance Matters 

The new guidance represents a significant step toward a more innovation-friendly EU regulatory environment, aligning patient access, scientific rigor, and regulatory flexibility. For developers of highly innovative technologies, early regulatory strategy and engagement will be critical to fully leverage the opportunities offered by BtX designation. 

How can MedEnvoy Support 

MedEnvoy can help manufacturers understand the implications of this new EU guidance on breakthrough devices, by assisting in assessing the eligibility for BtX designation and preparing strong regulatory submissions aligned with applicable standards and guidance criteria. If you have any questions regarding this summary or the accompanying guidance document, we encourage you to contact our team for tailored support. Contact us so we can assist you.