MDCG guidance

MDCG 2024-15: Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED

MDCG guidance · Clinical investigation and evaluation · November 2024

Key facts

Reference MDCG 2024-15
Title Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
Topic Clinical investigation and evaluation
Published November 2024
Document health.ec.europa.eu

At a glance

  • Yes Full text searchable in Orca1
  • MDCG 2024-15 (November 2024) 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

Browse all MDCG guidance documents