MDCG 2024-3 Is Here | Are Your PMS Plans Ready
Автор: MedEnvoy Global
Загружено: 2026-01-20
Просмотров: 7
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In this week's episode of our Regulatory Roundup, we break down MDCG 2024-3, the long-awaited guidance on the content of Post-Market Surveillance (PMS) plans under the EU MDR.
Read the full news article here: https://medenvoyglobal.com/blog/eu-pu...
We explain what Notified Bodies now expect to see in a compliant PMS plan, how this guidance clarifies Article 84 of the MDR, and why PMS must be a proactive, systematic process; not just complaint handling. You’ll learn how PMS connects to PMCF, risk management, clinical evaluation, and PSURs, plus practical next steps like conducting a gap analysis against the new structure.
Disclaimer: This episode was created and hosted by AI
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