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.
MedNet EC-REP
Author
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.
Related Articles
EUDAMED’s first four modules become mandatory on 28 May 2026 - what this means for medical device manufacturers
The European Commission (EC) has formally declared that the first four modules of EUDAMED - the European Database on Medical Devices - will become mandatory as of 28 May 2026.
MHRA Introduces New Device Registration Fee: What Manufacturers Need to Know
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its “DORS Fees Guidance 2.1”, introducing a new annual fee model for device registration.
Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR
European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance. This bulletin clarifies the regulatory definitions, their implications, and guidance interpretations.
Stay Updated
Get the latest regulatory updates and industry insights delivered to your inbox.
Subscribe to Updates