MDCG guidance

MDCG 2019-9 - Rev.1: Summary of safety and clinical performance

MDCG guidance · Clinical investigation and evaluation · March 2022

Key facts

Reference MDCG 2019-9 - Rev.1
Title Summary of safety and clinical performance
Topic Clinical investigation and evaluation
Published March 2022
Document health.ec.europa.eu

At a glance

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  • MDCG 2019-9 - Rev.1 (March 2022) 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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