Regulatory Background
In line with this regulatory framework, the EU requires manufacturers to implement a structured PMS system as an integral part of their quality management system. The PMS system must actively collect and analyze post-market data to confirm that devices continue to meet the applicable general safety and performance requirements throughout their intended lifetime.
Scope of PMS Activities
The PMS obligations apply to all medical devices and IVDs marketed in the EU and include the preparation of a documented PMS Plan describing data sources, analysis methods, and corrective actions. PMS activities may include complaint handling, vigilance reporting, trend analysis, post-market clinical follow-up (PMCF), post-market performance follow-up (PMPF), and scientific literature review.
Scope of PMS Activities
Manufacturers are required to document PMS outcomes through periodic reports based on device risk classification. Class I medical devices require a Post-Market Surveillance Report (PMSR), while higher-risk devices must be supported by a Periodic Safety Update Report (PSUR). For IVDs, similar reporting obligations apply in accordance with IVDR risk classes.
Regulatory Impact
This guidance ensures a consistent and proactive approach to post-market oversight, supporting early detection of safety signals, continuous risk management, and ongoing regulatory compliance in the EU market.
Unlock Your Medical Device Potential with Us
Effective implementation of post-market surveillance requirements under MDR and IVDR is essential for maintaining EU market access. Qualtech brings over 26 years of experience supporting medical device and IVD manufacturers in establishing compliant PMS systems, preparing PMSR and PSUR documentation, and managing ongoing post-market obligations.
Connect with us today to strengthen your post-market surveillance strategy and ensure sustained compliance in the EU market.
Reference
Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices