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Breakthrough devices

EU guidance or pilot pathways for breakthrough devices.

Official catalogue · non-binding

Breakthrough devices guidance (1)

Catalogue entries are ordered as they appear in the European Commission catalogue.

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MDCG 2025-9Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026December 2025
Non-binding guidanceOpen guidance page
Catalogue section
New technologies
Published
December 2025
Topics

Source document

  • MDCG 2025-9PDF · Unverified extraction previewOfficial source

    Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.

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