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EU MDR MDCG

MDCG 2019-16 Rev. 1

Guidance on Cybersecurity for Medical Devices
European UnionMDCGSoftware/SaMD
What this code is

MDCG 2019-16 Rev. 1 is the official MDCG identifier for “Guidance on Cybersecurity for Medical Devices”. MDCG 2019-16 Rev. 1 is the official identifier MDCG uses for this instrument.

Instrument
MDCG
Full name
MDCG 2019-16 Rev. 1
Category
Software/SaMD
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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39 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
December 2019
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 Cybersecurity for Medical Devices

MDCG 2019-16 Rev. 1 cybersecurity guidance. Cover states December 2019 with July 2020 rev.1. Ingested as numbered sections sec-1 through sec-10 (Annexes I–IV as sec-7–sec-10) from the official PDF.

MDCG 2019-16 Rev. 1 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.