MDCG 2025-10: New PMS Guidance for MDR & IVDR
The MDCG released new PMS guidance in December 2025. Learn what MDCG 2025-10 means for your MDR and IVDR compliance strategy.
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New MDCG Guidance on Post-Market Surveillance: What Manufacturers Need to Know
In December 2025, the Medical Device Coordination Group (MDCG) released MDCG 2025-10, a new guidance document focused on Post-Market Surveillance (PMS) for medical devices and in-vitro diagnostic medical devices placed on the EU market.
The guidance supports the implementation of the requirements under
Regulation (EU) 2017/745 (MDR) and
Regulation (EU) 2017/746 (IVDR).
While the document does not introduce new legal obligations, it provides much-needed clarification on how manufacturers should design and operate effective PMS systems.
For manufacturers navigating the transition to the MDR and IVDR framework, this guidance is an important reference.
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