Regulatory Services

BSI Breakthrough Device Pathway (BtX)

A service specifically designed to support the timely conformity assessment of breakthrough medical technologies.

BSI’s Breakthrough (BtX) Pathway combines early expert dialogue with prioritized conformity assessments to accelerate market access for innovative medical technologies.

A device may be considered as a Breakthrough device under the MDR and IVDR in accordance with MDCG 2025-9 when it meets the following criteria:

Novelty

The device introduces a high degree of novelty with respect to the device technology, the related clinical procedure, and/or the application of the device in clinical practice. 

AND

Positive clinical impact

You need to submit your device documentation to the EMA expert panel who will verify that your device meets the eligibility criteria as laid down in MDCG 2025-9.

Once your device is designated as a breakthrough device by the EMA expert panel, it can be enrolled into the BSI BtX Pathway. 

MDCG 2025-9

Why BSI BtX Pathway.

Early engagement for high-impact innovation.

The BSI BtX Pathway targets devices for serious or life-threatening conditions, where innovation and regulatory complexity require early, informed engagement throughout certification.

Regulatory Services

A unique opportunity to engage early and proactively with BSI.

Efficient pathways for transformative technologies.

Eligible devices enrolled in the BSI BtX benefit from the BSI Dedicated Interactive Review Service through gaining priority in the review queue. This priority review is offered at standard pricing.

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Clarity and informed critical decisions.

Early, structured interaction with BSI helps clarify regulatory, clinical evidence expectations, and applicable conformity routes - reducing uncertainty and costly late-stage changes. The BtX Pathway supports informed decision-making and regulatory planning, helping manufacturers focus resources where they matter most.

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Supporting innovation that matters.

The BtX Pathway is designed for technologies with the potential to deliver meaningful clinical or public health benefits where alternatives are limited or insufficient.

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