Post-Market Surveillance

Post-Market Surveillance for Medical Devices

Post-market surveillance (PMS) is a critical regulatory and quality assurance function that ensures medical devices remain safe, effective, and compliant throughout their lifecycle. Under the EU MDR and IVDR, manufacturers must implement systematic processes to monitor product performance, manage risks, and maintain conformity after CE marking has been achieved.

Key focus areas include Post-Market Clinical Follow-Up (PMCF), lifecycle support for CE marking, and strategies for compliance remediation. In addition, effective PMS involves the ongoing monitoring of process and product safety, validation of design and manufacturing changes, and the structured maintenance of technical documentation. Together, these activities support continuous regulatory alignment and strengthen overall product stewardship.