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Medical Breakthrough Devices (BtX)

Supporting earlier market access for novel medical devices

White paper

17 Sept 2026

MDCG 2025-9 introduces the European Union’s regulatory pathway for Breakthrough Devices (BtX), providing manufacturers of transformative medical devices with a structured framework to support earlier EU market access while maintaining patient safety.  

For BtX designation, devices must meet two cumulative criteria: 

  • Novelty: Demonstrate a high degree of technological or clinical innovation.  
  • Positive clinical impact: Deliver meaningful benefits for patients with life-threatening or irreversibly debilitating conditions. 

BtX designation does not lower regulatory requirements or guarantee CE marking. Instead, it supports a structured approach to clinical evidence across the product lifecycle while maintaining the high standards required under the EU MDR. 

MDR - Your BtX Pathway
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Supporting medical device innovation with TÜV SÜD

Our multidisciplinary team of experts, including clinical, technical and regulatory specialists from various fields, understands the challenges associated with highly innovative medical devices. Through early engagement and structured dialogue, the BtX framework facilitates a clearer understanding of the applicable EU MDR requirements. 

TÜV SÜD applies clinical, technical and regulatory expertise in the independent assessment of medical devices within the defined BtX and MDR conformity assessment framework. The BtX designation allows manufacturers to: 

  • Reduce regulatory process uncertainty by engaging with a Notified Body early on. 
  • Have structured dialogues to clarify submission requirements and clinical evidence expectations prior to formal assessment.  
  • Build a BtX evidence strategy justifying initial pre-market clinical evidence while incorporating acceptable residual uncertainties into robust post-market plans.  
  • Receive guidance from Medical Device Expert Panels on the clinical strategy and balance between pre- and post-certification clinical evidence. 
  • Receive a prioritised, risk-based technical documentation assessment, with an option for conditional MDR certification.  

Explore the BtX pathway

Contact our multidisciplinary experts to learn more about the BtX pathway and conformity assessment, helping ensure medical innovations are safe and effective.
    Contact our experts

    About the authors

    Dr Langhit Kurar

    Dr. Langhit Kurar

    Clinical Reviewer and Orthopaedic Subject Matter Expert, TÜV SÜD

    Langhit Kurar is a UK-based orthopaedic surgeon with more than ten years of clinical experience across trauma, orthopaedics and emergency medicine. At TÜV SÜD he reviews clinical evidence under the EU MDR, with a focus on orthopaedic implants, high-risk technologies, breakthrough device pathways and clinical evaluation strategy. His work includes cross-functional regulatory discussion and development of internal approaches for novel and high-impact medical devices.

    Dr Nikhil Khadabadi

    Dr. Nikhil Khadabadi

    Chief Medical Officer, Eclevar MedTech

    Dr Nikhil Khadabadi is an orthopaedic surgeon and former notified body Clinical Reviewer with experience in EU MDR clinical evaluation, post-market clinical follow-up (PMCF), clinical evidence strategy and high risk medical device submissions. At Eclevar MedTech, he leads clinical and regulatory strategy across orthopaedics, spine, wound care and emerging medical technologies. His work focuses on translating regulatory expectations into practical evidence generation plans for manufacturers, including CER, PMCF, real-world evidence, clinical investigations and postmarket strategy. 

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