MDCG guidance

2023/C 163/06: Commission Guidance on the content and structure of the summary of the clinical investigation report

MDCG guidance · Clinical investigation and evaluation · May 2023

Key facts

Reference 2023/C 163/06
Title Commission Guidance on the content and structure of the summary of the clinical investigation report
Topic Clinical investigation and evaluation
Published May 2023
Document eur-lex.europa.eu

At a glance

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  • 2023/C 163/06 (May 2023) Revisions on file

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About MDCG guidance documents

The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.

Source: European Commission, Medical Device Coordination Group (MDCG) endorsed documents and other guidance. © European Union, reused under Commission Decision 2011/833/EU

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