EU MDR MDCGMDCG 2025-9
Guidance on Breakthrough Devices (BtX)
European UnionMDCGRegistration
What this code is
MDCG 2025-9 is the official MDCG identifier for “Guidance on Breakthrough Devices (BtX)”. MDCG 2025-9 is the official identifier MDCG uses for this instrument.
- Instrument
- MDCG
- Full name
- MDCG 2025-9
- Category
- Registration
Source links
- Authority source
- English
- Readable HTML
- 38 articles · 1 language version
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
- Published
- December 2025
- Effective
- —
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
About this regulation
Guidance on Breakthrough Devices (BtX)
MDCG 2025-9 (December 2025) Breakthrough Devices guidance. Ingested as numbered sections sec-1 through sec-14 from the official PDF. Not part of the EUR-Lex binding-text family.
MDCG 2025-9 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.