MDCG guidance

MDCG 2023-3 rev.1: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746

MDCG guidance · Post-Market Surveillance and Vigilance (PMSV) · November 2024

Key facts

Reference MDCG 2023-3 rev.1
Title Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746
Topic Post-Market Surveillance and Vigilance (PMSV)
Published November 2024
Document health.ec.europa.eu

At a glance

  • Yes Full text searchable in Orca1
  • MDCG 2023-3 rev.1 (November 2024), MDCG 2023-3 (February 2023) Revisions on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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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