BSI, in its capacity as a medical device and in vitro diagnostic Notified Body, has launched its Breakthrough (BtX) Device Pathway. It is a special pathway designed to support manufacturers, especially SMEs and Startups, developing truly innovative medical devices and in vitro diagnostic technologies.
Eligible devices enrolled in the BSI BtX benefit from the BSI Dedicated Interactive Review Service and gain priority in the review queue. This review service is offered at standard pricing. The BSI BtX Pathway enables a more predictable and efficient progression through the required conformity assessment. It helps manufacturers to achieve early market access for truly innovative devices.
Eligibility for the BtX Pathway is determined through submission of device documentation to the EMA expert panel, which verifies compliance with the criteria set out in MDCG 2025-9 - Guidance on Breakthrough Devices (BtX) under Regulations (EU) 2017/745 and 2017/746. Once breakthrough status is confirmed, manufacturers can enroll in the BSI BtX Pathway and access its associated benefits.
The BtX Pathway can be combined with BSI Structured Dialogue, enabling manufacturers to benefit from consistent, expert discussions from the earliest stages and throughout the certification process. This integrated approach helps clarify regulatory requirements, clinical evidence expectations, and conformity assessment requirements at critical stages of development and conformity assessments.
BSI's Head of Medical Devices Notified Body, Maddalena Pinsi, says: "By taking an integrated approach, we are giving innovators greater predictability across the development and regulatory journey, while removing unnecessary delays to market entry. This enables truly transformative and life-saving technologies to reach patients fast, with a framework that supports innovation and maintains confidence in the system."
By engaging early through the BtX Pathway, manufacturers can:
- Reduce regulatory uncertainty
- Optimize clinical and regulatory planning
- Accelerate decision-making
- Progress more efficiently toward market access for devices that address unmet medical needs
Supporting innovation with regulatory excellence
The launch of the BtX Pathway reinforces BSI’s commitment to support innovative medical technologies. By providing streamlined, priority access and expert regulatory guidance BSI helps manufacturers, especially SMEs and Startups, to offer their breakthrough devices to patients while maintaining the highest standards of safety and compliance.
Further Information and Resources
Manufacturers interested in the BSI Breakthrough Device Pathway can access additional information and download a dedicated brochure via the BSI website.
To further support understanding of EU regulatory requirements, please register now for BSI's Insight Series: Startup Edition Webinars with the next one scheduled for 20 May 2026.
Whether beginning the certification journey or evaluating regulatory options for innovative technologies, BSI provides expert guidance at every step.
Sincerely,
Maddalena Pinsi
Head of Medical Devices Notified Body, BSI
