MDCG guidance

MDCG 2024-11: Guidance on qualification of in vitro diagnostic medical devices

MDCG guidance · In Vitro Diagnostic medical devices (IVD) · October 2024

Key facts

Reference MDCG 2024-11
Title Guidance on qualification of in vitro diagnostic medical devices
Topic In Vitro Diagnostic medical devices (IVD)
Published October 2024
Document health.ec.europa.eu

At a glance

  • Yes Full text searchable in Orca1
  • MDCG 2024-11 (October 2024) 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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