Post-Market Surveillance & Vigilance
The transition from directive-based requirements to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) has transformed post-market surveillance (PMS) into a central element of regulatory compliance. Manufacturers are now required to demonstrate ongoing control of device performance, safety, and benefit-risk balance through systematic data collection, analysis, and reporting. Regulators expect a proactive surveillance system that generates meaningful evidence and links directly to risk management and clinical evaluation processes. Many organisations, however, struggle to operationalise these requirements. Disconnected procedures, inconsistent data sources, and under-resourced vigilance activities often result in reactive, rather than preventive, compliance management.
Our Post-Market Surveillance and Vigilance services provide a structured, integrated approach to meeting these heightened expectations. We begin by evaluating existing PMS systems, including data collection processes, complaint handling workflows, and vigilance reporting practices. Each element is reviewed against MDR Annex III, Articles 83–86, and corresponding IVDR provisions to identify procedural or evidentiary gaps. The outcome is a diagnostic assessment that establishes a clear remediation plan, prioritising activities according to regulatory risk and operational feasibility.
We then support the design and implementation of a complete PMS plan that defines data sources, monitoring methods, responsibilities, and escalation pathways. Our frameworks incorporate information from multiple channels, including customer feedback, service records, clinical follow-up, literature reviews, and registry data. We ensure that data flows are clearly mapped and linked to device risk profiles, allowing for efficient trend analysis and signal detection.
Vigilance procedures are established in parallel, covering serious incident reporting, field safety corrective actions (FSCA), and coordination with Competent Authorities and Notified Bodies. We develop templates and workflows that ensure reports are accurate, timely, and fully documented, meeting the strict submission deadlines and format requirements set by regulators. Our consultants also provide guidance on the practical aspects of incident investigation, root cause analysis, and CAPA linkage to ensure that every corrective measure is both scientifically justified and traceable.
Periodic Safety Update Reports (PSURs) and Post-Market Clinical Follow-Up (PMCF) activities form another essential component of our service. We assist in the preparation of PSURs that synthesise safety and performance data into a structured analysis aligned with device classification and intended purpose. Where clinical data gaps exist, we design PMCF plans and studies that generate targeted evidence to support ongoing conformity and product claims. This ensures that surveillance findings feed back into continuous improvement of both product design and risk management documentation.
Effective post-market surveillance is more than a regulatory requirement—it is an ongoing commitment to product performance and patient safety. Our services provide the structure, evidence, and oversight necessary to sustain compliance and regulatory confidence throughout the entire product lifecycle.
For further information on how our Post-Market Surveillance and Vigilance services can strengthen your compliance and risk management frameworks, please contact our regulatory affairs team.
