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
Well-Established Technologies Under the MDR: EU Commission Expands Exemption List
The EU Commission has expanded the WET list under the MDR, easing requirements for certain class II and class III devices.
MHRA Device Registration: New Clarification on "Placing on the Market" and "Putting into Service" (Update 20 July 2026)
MHRA clarifies medical device registration: 20 July 2026 update explains "placing on the market" vs. "putting into service" in GB.
EC REP Becomes EU REP: What the New Authorised Representative Symbol Means for Medical Device Manufacturers
In short: On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) for both the MDR and the IVDR. This amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union. The change is purely editorial, and you have a five-year transition period - until 17 June 2031 - during which both symbols remain valid.
Stay Updated
Get the latest regulatory updates and industry insights delivered to your inbox.
Subscribe to Updates