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EU MDR MDCG

MDCG 2020-1

Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR)
European UnionMDCGClinical Trials
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What this code is

MDCG 2020-1 is the official MDCG identifier for “Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR)”. MDCG 2020-1 is the official identifier MDCG uses for this instrument.

Instrument
MDCG
Full name
MDCG 2020-1
Category
Clinical Trials
Source links
Authority source
English
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21 articles · 1 language version
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Dates
Published
March 2020
Effective
—
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English full text21 articles · English — official textRead HTML →
About this regulation

Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR)

Exact MDCG PDF for clinical/performance evaluation of medical-device software. Ingested with the complete official outline, including 4.4.1/4.4.2 clauses, Annex I, and Annex II examples a)–f).

MDCG 2020-1 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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