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IMDRF Strategic Plan 2026-2030
IMDRF is committed to sustaining its strong global leadership while continuing to meet the needs of and engage with its growing number of members and stakeholders. In recent years, IMDRF has led globally in expanding its offerings, now conducting training and...
EMA Medicines – Revised Classification of Changes Guidance
EMA has published its updated “Classification of changes” guidance (Nov 2025) the procedural framework for classifying and submitting variations to marketing authorisations for medicinal products in the European Union. This guidance governs how companies should manage...
EU MDCG Guidance : BtX – Breakthrough Devices under MDR & IVDR
The Medical Device Coordination Group has published MDCG 2025-9 – Guidance on Breakthrough Devices (BtX) under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). This guidance introduces a structured EU framework to support the development, conformity assessment,...
EU MDCG News!! (Post-Market Surveillance Guidance Published)
The Medical Device Coordination Group (MDCG) has released MDCG 2025-10 – Guidance on Post-Market Surveillance (PMS) of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025). This document supports manufacturers in understanding and implementing...
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