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EU MDR MDCG

MDCG 2025-6

FAQ on MDR/IVDR and Artificial Intelligence Act
European UnionMDCGSoftware/SaMD
What this code is

MDCG 2025-6 is the official MDCG identifier for “FAQ on MDR/IVDR and Artificial Intelligence Act”. MDCG 2025-6 is the official identifier MDCG uses for this instrument.

Instrument
MDCG
Full name
MDCG 2025-6
Category
Software/SaMD
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
36 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
June 2025
Effective
Readable full text

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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

FAQ on MDR/IVDR and Artificial Intelligence Act

Exact MDCG FAQ PDF on MDR/IVDR and the AI Act. Ingested with FAQ-question anchors q-1–q-36 plus the five official theme sections.

MDCG 2025-6 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.